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Innolitics
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
FPX
Strip, Adhesive, Closure, Skin
1
Product Code
FPY
Sheet, Burn
1
Product Code
KGX
Tape And Bandage, Adhesive
1
Product Code
KMF
Bandage, Liquid
1
Product Code
LRS
I.V. Start Kit
2
Product Code
MCY
Wound Dressing Kit
2
Product Code
K
97
0721
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
2
Cleared 510(K)
K
96
3719
CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
2
Cleared 510(K)
K
96
0585
WOUND CARE COMPRESSION SYSTEM (WCCS)
2
Cleared 510(K)
K
95
2334
DRESSING CHANGE TRAY
2
Cleared 510(K)
K
95
1021
CIRCULON SYSTEM STEP 2
2
Cleared 510(K)
K
95
1022
CIRCULON SYSTEM STEP 1
2
Cleared 510(K)
K
95
1476
E-PACK PROCEDURE KITS
2
Cleared 510(K)
K
93
1932
DRESSING CHANGE TRAY-MODIFIED
2
Cleared 510(K)
K
92
4690
VARIOUS NON-STERILE CUSTOM TRAYS/KITS
2
Cleared 510(K)
K
92
3905
WOUND DRESSING KIT
2
Cleared 510(K)
K
92
6063
PER-Q-CATH DRESSING CHANGE TRAY
2
Cleared 510(K)
K
92
5021
TPN TRAY (STERILE)
2
Cleared 510(K)
K
92
1347
CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER
2
Cleared 510(K)
K
91
3480
WOUND CARE TRAY A
2
Cleared 510(K)
K
91
2116
PRESSURE SORE MANAGEMENT KIT
2
Cleared 510(K)
K
91
2684
HOME MEDICAL KIT - FOR LITTLE HURTS
2
Cleared 510(K)
K
91
3479
WOUND CARE TRAY B
2
Cleared 510(K)
K
91
2232
ULCERCARE
2
Cleared 510(K)
K
91
2117
LACERATION TRAY
2
Cleared 510(K)
K
91
0363
MEGA DRESSING CHANGE KIT
2
Cleared 510(K)
K
91
0011
POST SURGICAL KIT/POST BIOPSY KIT
2
Cleared 510(K)
K
90
5123
G-TUBE DRESSING CHANGE TRAY
2
Cleared 510(K)
K
90
5572
EDLICH WOUND MANAGEMENT TRAY
2
Cleared 510(K)
K
90
2811
ROUTINE DRESSING TRAY
2
Cleared 510(K)
MHW
Dressing, Compression
1
Product Code
NEC
Bandage, Liquid, Skin Protectant
1
Product Code
OXQ
Dressing Change Tray
1
Product Code
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
1
Product Code
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
MCY
/
K910011
View Source
POST SURGICAL KIT/POST BIOPSY KIT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K910011
510(k) Type
Traditional
Applicant
DERMATOLOGICAL RESEARCH LABORATORIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/27/1991
Days to Decision
84 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
FPX
Strip, Adhesive, Closure, Skin
FPY
Sheet, Burn
KGX
Tape And Bandage, Adhesive
KMF
Bandage, Liquid
LRS
I.V. Start Kit
MCY
Wound Dressing Kit
K
97
0721
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
K
96
3719
CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
K
96
0585
WOUND CARE COMPRESSION SYSTEM (WCCS)
K
95
2334
DRESSING CHANGE TRAY
K
95
1021
CIRCULON SYSTEM STEP 2
K
95
1022
CIRCULON SYSTEM STEP 1
K
95
1476
E-PACK PROCEDURE KITS
K
93
1932
DRESSING CHANGE TRAY-MODIFIED
K
92
4690
VARIOUS NON-STERILE CUSTOM TRAYS/KITS
K
92
3905
WOUND DRESSING KIT
K
92
6063
PER-Q-CATH DRESSING CHANGE TRAY
K
92
5021
TPN TRAY (STERILE)
K
92
1347
CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER
K
91
3480
WOUND CARE TRAY A
K
91
2116
PRESSURE SORE MANAGEMENT KIT
K
91
2684
HOME MEDICAL KIT - FOR LITTLE HURTS
K
91
3479
WOUND CARE TRAY B
K
91
2232
ULCERCARE
K
91
2117
LACERATION TRAY
K
91
0363
MEGA DRESSING CHANGE KIT
K
91
0011
POST SURGICAL KIT/POST BIOPSY KIT
K
90
5123
G-TUBE DRESSING CHANGE TRAY
K
90
5572
EDLICH WOUND MANAGEMENT TRAY
K
90
2811
ROUTINE DRESSING TRAY
MHW
Dressing, Compression
NEC
Bandage, Liquid, Skin Protectant
OXQ
Dressing Change Tray
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
MCY
/
K910011
View Source
POST SURGICAL KIT/POST BIOPSY KIT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K910011
510(k) Type
Traditional
Applicant
DERMATOLOGICAL RESEARCH LABORATORIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/27/1991
Days to Decision
84 days