FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
FLG
Cleaner, Ultrasonic, Medical Instrument
1
Product Code
FLH
Washer Of Body Waste Receptacles
1
Product Code
FLI
Cabinet, Ethylene-Oxide Gas Aerator
2
Product Code
BRT
Restraint, Patient, Conductive
1
Product Code
BYY
Tube, Aspirating, Flexible, Connecting
2
Product Code
BYZ
Trap, Sterile Specimen
2
Product Code
CBC
Bottle, Collection And Trap, Breathing System (Uncalibrated)
2
Product Code
CBD
Bottle, Collection, Breathing System (Calibrated)
2
Product Code
FLE
Sterilizer, Steam
2
Product Code
FLF
Sterilizer, Ethylene-Oxide Gas
2
Product Code
FMA
Depressor, Tongue, Non-Surgical
1
Product Code
FMC
Patient Examination Glove
1
Product Code
FME
Gown, Examination
1
Product Code
FML
Chair, Blood Donor
1
Product Code
FMP
Protector, Skin Pressure
1
Product Code
FMQ
Restraint, Protective
1
Product Code
FMR
Device, Transfer, Patient, Manual
1
Product Code
FMW
Cover, Mattress (Medical Purposes)
1
Product Code
FNP
Urinal
1
Product Code
FNS
Ring Cutter
1
Product Code
FNY
Basin, Emesis
1
Product Code
FOA
Board, Cardiopulmonary
1
Product Code
FOB
Bedpan
1
Product Code
FOX
Stand, Infusion
1
Product Code
FPF
Bottle, Hot/Cold Water
1
Product Code
FPO
Stretcher, Wheeled
2
Product Code
FPP
Stretcher, Hand-Carried
1
Product Code
FPS
Board, Bed
1
Product Code
FRA
Purifier, Air, Ultraviolet, Medical
2
Product Code
FRG
Wrap, Sterilization
2
Product Code
FRJ
Chair, Geriatric
1
Product Code
FRK
Chair, Examination And Treatment
1
Product Code
FRZ
Device, Patient Transfer, Powered
2
Product Code
GAZ
Tubing, Noninvasive
2
Product Code
GCX
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
2
Product Code
JOK
Scissors, Medical, Disposable
1
Product Code
JOL
Catheter And Tip, Suction
2
Product Code
KCT
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
2
Product Code
KDP
Regulator, Vacuum
2
Product Code
KDQ
Bottle, Collection, Vacuum
2
Product Code
KIA
Cover, Cast
1
Product Code
KME
Bedding, Disposable, Medical
1
Product Code
KMG
Purifier, Water, Ultraviolet, Medical
2
Product Code
KMH
Sterilizer, Dry Heat
2
Product Code
KMJ
Lubricant, Patient
1
Product Code
KMN
Chair And Table, Medical
1
Product Code
KXF
Applicator, Absorbent Tipped, Non-Sterile
1
Product Code
KXG
Applicator, Absorbent Tipped, Sterile
1
Product Code
KYR
Bag, Ice
1
Product Code
KYS
Insoles, Medical
1
Product Code
KYT
Light, Examination, Medical, Battery Powered
1
Product Code
KYW
Container, Liquid Medication, Graduated
1
Product Code
KYX
Dispenser, Liquid Medication
1
Product Code
KYZ
Syringe, Irrigating (Non Dental)
1
Product Code
KZA
Device, Vein Location, Liquid Crystal
1
Product Code
KZF
Device, Medical Examination, Ac Powered
1
Product Code
KZH
Introducer, Syringe Needle
2
Product Code
LBJ
Device, Vein Stabilization
1
Product Code
LDS
Device, Pasteurization, Hot Water
2
Product Code
LRJ
Disinfectant, Medical Devices
1
Product Code
K
99
2661
CONTROL III ELITE
1
Cleared 510(K)
K
99
1509
PRO-PORTION CLEANER/DISINFECTANT
1
Cleared 510(K)
K
98
4485
MICROSTAT 2
1
Cleared 510(K)
K
98
3947
AMERSE 2
1
Cleared 510(K)
K
98
3869
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
1
Cleared 510(K)
K
98
3585
LOW PH PHENOLIC 256
1
Cleared 510(K)
K
98
2985
CITREX HOSPITAL SPRAY DISINFECTANT
1
Cleared 510(K)
K
98
1023
KLEENASEPTIC
1
Cleared 510(K)
K
98
0369
T.B.Q. RTU
1
Cleared 510(K)
K
97
4304
GERMICIDAL CLOTH
1
Cleared 510(K)
K
96
1044
NOVIGUARD QUICK DRY
1
Cleared 510(K)
K
97
0825
BLUE CHIP GERMICIDAL CLEANER & DEODORANT
1
Cleared 510(K)
K
96
4376
CIDE-SWIPES P-100B & CIDE-SWIPES C-100A
1
Cleared 510(K)
K
96
4828
VIREX II 128 GERMICIDAL CLEANER AND DEODORANT
1
Cleared 510(K)
K
96
4835
COVERAGE SPRAY HBV
1
Cleared 510(K)
K
96
4749
COVERAGE HBV
1
Cleared 510(K)
K
96
4610
TRIAD II DISINFECTANT CLEANER AND DEODORANT
1
Cleared 510(K)
K
96
4613
VIREX II 256 GERMICIDAL CLEANER AND DEODORANT
1
Cleared 510(K)
K
96
4535
VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT
1
Cleared 510(K)
K
96
3353
LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46)
1
Cleared 510(K)
K
96
2739
T.B.Q.
1
Cleared 510(K)
K
96
0836
DMS-9000
1
Cleared 510(K)
K
96
0580
BEAUCOUP GENERAL PURPOSE DISINFECTANT
1
Cleared 510(K)
K
96
0583
MATAR GENERAL PURPOSE DISINFECTANT
1
Cleared 510(K)
K
96
0582
ASCEND GENERAL PURPOSE DISINFECTANT
1
Cleared 510(K)
K
95
5850
PRO-TECH
1
Cleared 510(K)
K
92
3693
KLORMAN
1
Cleared 510(K)
K
93
4150
BIOCIDE CLEANER/DISINFECTANT
1
Cleared 510(K)
K
93
4014
VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
1
Cleared 510(K)
K
95
2929
LD GENERAL PURPOSE DISINFECTANT
1
Cleared 510(K)
K
95
4292
Q5. 5-5.5NPB-2.5HW
1
Cleared 510(K)
K
95
2405
CITRACE HOSPITAL GERMICIDAL DEODORIZER
1
Cleared 510(K)
K
95
2336
DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH
1
Cleared 510(K)
K
95
1020
TRI-CEN GERMICIDAL DETERGENT
1
Cleared 510(K)
K
95
3010
FORMULATION HWS-256 EPA REG. NO. 47371-129
1
Cleared 510(K)
K
95
3009
FORMULATION HWS-128 EPA REG. NO. 47371-130
1
Cleared 510(K)
K
95
3011
FORMULATION HWS-64 EPA REG. NO. 47371-131
1
Cleared 510(K)
K
95
1512
PRECISE HOSPITAL FOAM CLEANER DISINFECTANT
1
Cleared 510(K)
K
95
2302
AMUCHINA
1
Cleared 510(K)
K
95
1162
PHENO-CEN GERMICIDAL DETERGENT
1
Cleared 510(K)
K
94
1439
RENALIN COLD STERILANT
1
Cleared 510(K)
K
95
1983
IMNI-II
1
Cleared 510(K)
K
95
1317
PHENO-CEN SPRAY DISINFECTANT DEODORANT
1
Cleared 510(K)
K
95
1342
Q4.5-5.0PB-4.5
1
Cleared 510(K)
K
95
1123
CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER
1
Cleared 510(K)
K
94
0382
LYSOL I.C. BRAND DISINFECTANT
1
Cleared 510(K)
K
94
6078
HOSPITAL BROAD BAND CLEANDR - DISINFECTANT-DEODORANT
1
Cleared 510(K)
K
94
5227
OCIDE HOSPITAL CLEANER-DISINFECTANT
1
Cleared 510(K)
K
95
0553
COLDCIDE-2
1
Cleared 510(K)
K
95
0516
COLDCIDE-10
1
Cleared 510(K)
K
95
0324
MULTI-WASH
1
Cleared 510(K)
K
94
4179
CONTROL III DISINFECTANT GERMICIDE
1
Cleared 510(K)
K
94
4037
DIACIDE HD DISINFECTING SOLUTION
1
Cleared 510(K)
K
94
0383
LYSOL I.C. BRAND INSTRUMENT DISINFECTANT PRESOAK
1
Cleared 510(K)
K
94
0400
LYSOL I.C. BRAND DISINFECTANT SPRAY
1
Cleared 510(K)
K
94
0381
LYSOL I.C. BRAND QUATERNARY CLEANER DISINFECTANT
1
Cleared 510(K)
K
93
1477
AMERSE
1
Cleared 510(K)
K
93
1816
VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM
1
Cleared 510(K)
K
93
1342
LPH
1
Cleared 510(K)
K
93
1573
VESPHENE II
1
Cleared 510(K)
K
93
2502
LONZA FORMULATION R-82
1
Cleared 510(K)
K
93
2277
LONZA FORMULATION R-82
1
Cleared 510(K)
K
92
4434
CIDEX ACTIVATED DIALDEHYDE SOLUTION
1
Cleared 510(K)
K
92
3744
CIDEX PLUS 28 DAY SOLUTION
1
Cleared 510(K)
K
92
6013
SPORICIDIN BRAND DISINFECT TOWEL, SPRAY/SOLUT MODI
1
Cleared 510(K)
K
92
2262
SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT
1
Cleared 510(K)
K
90
4579
SPORICIDIN BRAND DISINFECTANT TOWELETTES
1
Cleared 510(K)
K
90
4581
SPORICIDIN BRAND DISINFECTANT SOLUTION
1
Cleared 510(K)
K
90
4580
SPORICIDIN BRAND DISINFECTANT SPRAY
1
Cleared 510(K)
K
88
2564
RENALIN COLD STERILANT
1
Cleared 510(K)
K
87
0759
CLEANING SOLUTION, CATALOG NO. 8203
1
Cleared 510(K)
K
87
0276
HEATED INSTRUMENT BATH
1
Cleared 510(K)
LYY
Latex Patient Examination Glove
1
Product Code
LYZ
Vinyl Patient Examination Glove
1
Product Code
LZA
Polymer Patient Examination Glove
1
Product Code
LZB
Finger Cot
1
Product Code
LZC
Patient Examination Glove, Specialty
1
Product Code
MDZ
Cleaners, Medical Devices
2
Product Code
MEC
Disinfector, Medical Devices
2
Product Code
MED
Sterilant, Medical Devices
2
Product Code
MKB
Device, Germicidal, Ultraviolet
2
Product Code
MLR
Sterilizer, Chemical
2
Product Code
MMS
Lubricant, Vaginal, Patient
1
Product Code
MTV
Sharps Needle Destruction Device
2
Product Code
NRV
Implantable Radio Frequency Transponder System
2
Product Code
NZD
Stretcher, Patient Restraint
1
Product Code
NZH
Medication Management System, Remote
2
Product Code
NZJ
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
2
Product Code
OHY
Pill Crusher/Cutter
1
Product Code
OIG
Powder-Free Guayle Rubber Examination Glove
1
Product Code
PEQ
Accessories To Examination Light
1
Product Code
OPC
Powder-Free Polychloroprene Patient Examination Glove
1
Product Code
OPH
Radiation Attenuating Medical Glove
1
Product Code
OPI
Antimicrobial Medical Glove
1
Product Code
OPJ
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
1
Product Code
ORW
N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
2
Product Code
OSZ
Antimicrobial Keyboard
2
Product Code
OUG
Medical Device Data System
1
Product Code
OVY
Liquid Chemical Processing System
2
Product Code
OYS
Patient Bed With Canopy/Restraints
1
Product Code
PAD
Chest Drainage Kit
2
Product Code
PEC
Sterilizer Automated Loading System
2
Product Code
PJJ
Two Or More Sterilant Sterilizer
2
Product Code
PWM
Admission Kit (Patient Utensil)
1
Product Code
PYQ
Rfid Chip For Dental Appliance
2
Product Code
PWP
Blood Borne Pathogen Response Kit
1
Product Code
PWS
Chemotherapy Administration Kit
1
Product Code
PWT
Chemotherapy Spill Clean-Up Kit
1
Product Code
PWU
Clean-Up Kit
1
Product Code
PWV
Delivery Room Apparel Kit
1
Product Code
PWZ
Mid-Stream Collection Kit
1
Product Code
PXA
Oral Administration Set
1
Product Code
PXC
Personal Protection Kit
1
Product Code
PXD
Prep Kit
1
Product Code
PXF
Sitz Bath Kit
1
Product Code
PXG
Spill Kit
1
Product Code
PXM
Vomitus Clean-Up Kit
1
Product Code
QDO
Fentanyl And Other Opioid Protection Glove
1
Product Code
QTV
Mattress And Bed Deck Cover (Medical Purposes)
1
Product Code
Subpart G—Miscellaneous Devices
CFR Sub-Part
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
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Review Panel
Medical Genetics
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Review Panel
Last synced on 16 May 2025 at 11:05 pm
HO
/
subpart-g—general-hospital-and-personal-use-miscellaneous-devices
/
LRJ
/
K923693
View Source
KLORMAN
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K923693
510(k) Type
Traditional
Applicant
MATRIX MEDICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/23/1996
Days to Decision
1279 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
FLG
Cleaner, Ultrasonic, Medical Instrument
FLH
Washer Of Body Waste Receptacles
FLI
Cabinet, Ethylene-Oxide Gas Aerator
BRT
Restraint, Patient, Conductive
BYY
Tube, Aspirating, Flexible, Connecting
BYZ
Trap, Sterile Specimen
CBC
Bottle, Collection And Trap, Breathing System (Uncalibrated)
CBD
Bottle, Collection, Breathing System (Calibrated)
FLE
Sterilizer, Steam
FLF
Sterilizer, Ethylene-Oxide Gas
FMA
Depressor, Tongue, Non-Surgical
FMC
Patient Examination Glove
FME
Gown, Examination
FML
Chair, Blood Donor
FMP
Protector, Skin Pressure
FMQ
Restraint, Protective
FMR
Device, Transfer, Patient, Manual
FMW
Cover, Mattress (Medical Purposes)
FNP
Urinal
FNS
Ring Cutter
FNY
Basin, Emesis
FOA
Board, Cardiopulmonary
FOB
Bedpan
FOX
Stand, Infusion
FPF
Bottle, Hot/Cold Water
FPO
Stretcher, Wheeled
FPP
Stretcher, Hand-Carried
FPS
Board, Bed
FRA
Purifier, Air, Ultraviolet, Medical
FRG
Wrap, Sterilization
FRJ
Chair, Geriatric
FRK
Chair, Examination And Treatment
FRZ
Device, Patient Transfer, Powered
GAZ
Tubing, Noninvasive
GCX
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
JOK
Scissors, Medical, Disposable
JOL
Catheter And Tip, Suction
KCT
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
KDP
Regulator, Vacuum
KDQ
Bottle, Collection, Vacuum
KIA
Cover, Cast
KME
Bedding, Disposable, Medical
KMG
Purifier, Water, Ultraviolet, Medical
KMH
Sterilizer, Dry Heat
KMJ
Lubricant, Patient
KMN
Chair And Table, Medical
KXF
Applicator, Absorbent Tipped, Non-Sterile
KXG
Applicator, Absorbent Tipped, Sterile
KYR
Bag, Ice
KYS
Insoles, Medical
KYT
Light, Examination, Medical, Battery Powered
KYW
Container, Liquid Medication, Graduated
KYX
Dispenser, Liquid Medication
KYZ
Syringe, Irrigating (Non Dental)
KZA
Device, Vein Location, Liquid Crystal
KZF
Device, Medical Examination, Ac Powered
KZH
Introducer, Syringe Needle
LBJ
Device, Vein Stabilization
LDS
Device, Pasteurization, Hot Water
LRJ
Disinfectant, Medical Devices
K
99
2661
CONTROL III ELITE
K
99
1509
PRO-PORTION CLEANER/DISINFECTANT
K
98
4485
MICROSTAT 2
K
98
3947
AMERSE 2
K
98
3869
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
K
98
3585
LOW PH PHENOLIC 256
K
98
2985
CITREX HOSPITAL SPRAY DISINFECTANT
K
98
1023
KLEENASEPTIC
K
98
0369
T.B.Q. RTU
K
97
4304
GERMICIDAL CLOTH
K
96
1044
NOVIGUARD QUICK DRY
K
97
0825
BLUE CHIP GERMICIDAL CLEANER & DEODORANT
K
96
4376
CIDE-SWIPES P-100B & CIDE-SWIPES C-100A
K
96
4828
VIREX II 128 GERMICIDAL CLEANER AND DEODORANT
K
96
4835
COVERAGE SPRAY HBV
K
96
4749
COVERAGE HBV
K
96
4610
TRIAD II DISINFECTANT CLEANER AND DEODORANT
K
96
4613
VIREX II 256 GERMICIDAL CLEANER AND DEODORANT
K
96
4535
VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT
K
96
3353
LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46)
K
96
2739
T.B.Q.
K
96
0836
DMS-9000
K
96
0580
BEAUCOUP GENERAL PURPOSE DISINFECTANT
K
96
0583
MATAR GENERAL PURPOSE DISINFECTANT
K
96
0582
ASCEND GENERAL PURPOSE DISINFECTANT
K
95
5850
PRO-TECH
K
92
3693
KLORMAN
K
93
4150
BIOCIDE CLEANER/DISINFECTANT
K
93
4014
VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
K
95
2929
LD GENERAL PURPOSE DISINFECTANT
K
95
4292
Q5. 5-5.5NPB-2.5HW
K
95
2405
CITRACE HOSPITAL GERMICIDAL DEODORIZER
K
95
2336
DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH
K
95
1020
TRI-CEN GERMICIDAL DETERGENT
K
95
3010
FORMULATION HWS-256 EPA REG. NO. 47371-129
K
95
3009
FORMULATION HWS-128 EPA REG. NO. 47371-130
K
95
3011
FORMULATION HWS-64 EPA REG. NO. 47371-131
K
95
1512
PRECISE HOSPITAL FOAM CLEANER DISINFECTANT
K
95
2302
AMUCHINA
K
95
1162
PHENO-CEN GERMICIDAL DETERGENT
K
94
1439
RENALIN COLD STERILANT
K
95
1983
IMNI-II
K
95
1317
PHENO-CEN SPRAY DISINFECTANT DEODORANT
K
95
1342
Q4.5-5.0PB-4.5
K
95
1123
CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER
K
94
0382
LYSOL I.C. BRAND DISINFECTANT
K
94
6078
HOSPITAL BROAD BAND CLEANDR - DISINFECTANT-DEODORANT
K
94
5227
OCIDE HOSPITAL CLEANER-DISINFECTANT
K
95
0553
COLDCIDE-2
K
95
0516
COLDCIDE-10
K
95
0324
MULTI-WASH
K
94
4179
CONTROL III DISINFECTANT GERMICIDE
K
94
4037
DIACIDE HD DISINFECTING SOLUTION
K
94
0383
LYSOL I.C. BRAND INSTRUMENT DISINFECTANT PRESOAK
K
94
0400
LYSOL I.C. BRAND DISINFECTANT SPRAY
K
94
0381
LYSOL I.C. BRAND QUATERNARY CLEANER DISINFECTANT
K
93
1477
AMERSE
K
93
1816
VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM
K
93
1342
LPH
K
93
1573
VESPHENE II
K
93
2502
LONZA FORMULATION R-82
K
93
2277
LONZA FORMULATION R-82
K
92
4434
CIDEX ACTIVATED DIALDEHYDE SOLUTION
K
92
3744
CIDEX PLUS 28 DAY SOLUTION
K
92
6013
SPORICIDIN BRAND DISINFECT TOWEL, SPRAY/SOLUT MODI
K
92
2262
SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT
K
90
4579
SPORICIDIN BRAND DISINFECTANT TOWELETTES
K
90
4581
SPORICIDIN BRAND DISINFECTANT SOLUTION
K
90
4580
SPORICIDIN BRAND DISINFECTANT SPRAY
K
88
2564
RENALIN COLD STERILANT
K
87
0759
CLEANING SOLUTION, CATALOG NO. 8203
K
87
0276
HEATED INSTRUMENT BATH
LYY
Latex Patient Examination Glove
LYZ
Vinyl Patient Examination Glove
LZA
Polymer Patient Examination Glove
LZB
Finger Cot
LZC
Patient Examination Glove, Specialty
MDZ
Cleaners, Medical Devices
MEC
Disinfector, Medical Devices
MED
Sterilant, Medical Devices
MKB
Device, Germicidal, Ultraviolet
MLR
Sterilizer, Chemical
MMS
Lubricant, Vaginal, Patient
MTV
Sharps Needle Destruction Device
NRV
Implantable Radio Frequency Transponder System
NZD
Stretcher, Patient Restraint
NZH
Medication Management System, Remote
NZJ
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
OHY
Pill Crusher/Cutter
OIG
Powder-Free Guayle Rubber Examination Glove
PEQ
Accessories To Examination Light
OPC
Powder-Free Polychloroprene Patient Examination Glove
OPH
Radiation Attenuating Medical Glove
OPI
Antimicrobial Medical Glove
OPJ
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
ORW
N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
OSZ
Antimicrobial Keyboard
OUG
Medical Device Data System
OVY
Liquid Chemical Processing System
OYS
Patient Bed With Canopy/Restraints
PAD
Chest Drainage Kit
PEC
Sterilizer Automated Loading System
PJJ
Two Or More Sterilant Sterilizer
PWM
Admission Kit (Patient Utensil)
PYQ
Rfid Chip For Dental Appliance
PWP
Blood Borne Pathogen Response Kit
PWS
Chemotherapy Administration Kit
PWT
Chemotherapy Spill Clean-Up Kit
PWU
Clean-Up Kit
PWV
Delivery Room Apparel Kit
PWZ
Mid-Stream Collection Kit
PXA
Oral Administration Set
PXC
Personal Protection Kit
PXD
Prep Kit
PXF
Sitz Bath Kit
PXG
Spill Kit
PXM
Vomitus Clean-Up Kit
QDO
Fentanyl And Other Opioid Protection Glove
QTV
Mattress And Bed Deck Cover (Medical Purposes)
Subpart G—Miscellaneous Devices
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
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subpart-g—general-hospital-and-personal-use-miscellaneous-devices
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LRJ
/
K923693
View Source
KLORMAN
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K923693
510(k) Type
Traditional
Applicant
MATRIX MEDICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/23/1996
Days to Decision
1279 days
Submission Type
Statement