FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
Dental
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
DZJ
Driver, Wire, And Bone Drill, Manual
2
Product Code
DZK
Wire, Fixation, Intraosseous
2
Product Code
DZL
Screw, Fixation, Intraosseous
2
Product Code
DZM
Needle, Dental
1
Product Code
DZN
Instruments, Dental Hand
1
Product Code
DZP
Instrument, Diamond, Dental
1
Product Code
DYX
Lock, Wire, And Ligature, Intraoral
2
Product Code
DZA
Drill, Dental, Intraoral
1
Product Code
DZH
Saw, Bone, Ac-Powered
2
Product Code
DZI
Drill, Bone, Powered
2
Product Code
EAX
Mirror, Mouth
1
Product Code
EAY
Light, Fiber Optic, Dental
1
Product Code
EAZ
Light, Operating, Dental
1
Product Code
EBA
Light, Surgical Headlight
1
Product Code
EBW
Controller, Foot, Handpiece And Cord
1
Product Code
ECB
Unit, Syringe, Air And/Or Water
1
Product Code
ECP
Instrument, Ligature Tucking, Orthodontic
1
Product Code
ECQ
Aligner, Bracket, Orthodontic
1
Product Code
ECR
Setter, Band, Orthodontic
1
Product Code
ECS
Pusher, Band, Orthodontic
1
Product Code
ECT
Driver, Band, Orthodontic
1
Product Code
EFA
Handpiece, Belt And/Or Gear Driven, Dental
1
Product Code
EFB
Handpiece, Air-Powered, Dental
1
Product Code
EFK
Forceps, Articulation Paper
1
Product Code
EFL
Forceps, Dressing, Dental
1
Product Code
EGI
Parallelometer
1
Product Code
EGM
Injector, Jet, Mechanical-Powered
2
Product Code
EGN
Scissors, Surgical Tissue, Dental
1
Product Code
EGQ
Injector, Jet, Gas-Powered
2
Product Code
EGS
Handpiece, Contra- And Right-Angle Attachment, Dental
1
Product Code
EIB
Syringe, Irrigating (Dental)
1
Product Code
EIC
Syringe, Periodontic, Endodontic, Irrigating
1
Product Code
EID
Syringe, Restorative And Impression Material
1
Product Code
EIF
Accessories, Retractor, Dental
1
Product Code
EIG
Retractor, All Types
1
Product Code
EIK
Carver, Wax, Dental
1
Product Code
EIL
Gauge, Depth, Instrument, Dental
1
Product Code
EIR
Scissors, Collar And Crown
1
Product Code
EIS
Remover, Crown
1
Product Code
EIX
Probe, Periodontic
1
Product Code
EIY
Instrument, Filling, Plastic, Dental
1
Product Code
EJB
Handle, Instrument, Dental
1
Product Code
EJY
Pliers, Operative
1
Product Code
EJZ
Knife, Margin Finishing, Operative
1
Product Code
EKA
File, Margin Finishing, Operative
1
Product Code
EKB
Explorer, Operative
1
Product Code
EKC
Excavator, Dental, Operative
1
Product Code
EKD
Instrument, Cutting, Operative
1
Product Code
EKE
Curette, Operative
1
Product Code
EKF
Instrument, Contouring, Matrix, Operative
1
Product Code
EKG
Condenser, Amalgam And Foil, Operative
1
Product Code
EKH
Carver, Dental Amalgam, Operative
1
Product Code
EKI
Carrier, Amalgam, Operative
1
Product Code
EKJ
Burnisher, Operative
1
Product Code
K
96
1714
ASEPTYLUM, UNI-CARRIER
1
Cleared 510(K)
K
95
3707
MEDTROL DENTAL KIT
1
Cleared 510(K)
K
94
5815
DENTAL KIT
1
Cleared 510(K)
K
95
1607
SUREFLEX FILES
1
Cleared 510(K)
K
94
5077
INSTRUMENT,FILLING,PLASTIC,DENTAL
1
Cleared 510(K)
K
94
3820
STAT PAK
1
Cleared 510(K)
K
94
3351
MAUNAL DISPOSABLE DENTAL INSTRUMENTS
1
Cleared 510(K)
K
94
3584
PRESTERILIZED ENDODONTIC FILES
1
Cleared 510(K)
K
93
5127
SOUTHLAND STERILE DENTAL SYSTEM
1
Cleared 510(K)
K
94
1954
NON-FOGGING DENTAL MIRROR
1
Cleared 510(K)
K
92
5115
AMD DENTIST AND HYGIENIST KITS
1
Cleared 510(K)
K
92
5890
MIRROR, MOUTH
1
Cleared 510(K)
K
92
5889
FORCEPS, DRESSING, DENTAL
1
Cleared 510(K)
K
92
5888
EXPLORER, OPERATIVE
1
Cleared 510(K)
K
93
5217
LC DENTAL HAND INSTRUMENT
1
Cleared 510(K)
K
93
2511
SILICONE MIRROR
1
Cleared 510(K)
K
92
6368
APPLICATOR NOZZLE
1
Cleared 510(K)
K
92
3902
STERILE DENTAL KITS
1
Cleared 510(K)
K
92
2988
ECO/DENTAL GENERAL DENTAL PACK
1
Cleared 510(K)
K
92
1354
BLUNT TIP IRRIGATION NEEDLES
1
Cleared 510(K)
K
91
4368
PART 872 DEGUFILL H & DEGUFILL M DA
1
Cleared 510(K)
K
91
1655
IMPLARETTE
1
Cleared 510(K)
K
91
2473
ACCU-PLACER TM KIT
1
Cleared 510(K)
K
91
1214
NUTIP (TM) SYRINGE SHIELD
1
Cleared 510(K)
K
91
2149
HARDCOATED PLASTIC FILLING INSTRUMENT
1
Cleared 510(K)
K
91
1281
PULPDENT PIC N STIC
1
Cleared 510(K)
K
90
1053
MIRROR SHIELD
1
Cleared 510(K)
K
90
1178
AMALGAM CONDENSER
1
Cleared 510(K)
K
90
1177
DISCOID/CLEOID DOUBLE END AMALGAM CARVER
1
Cleared 510(K)
K
90
1176
#23 EXPLORER
1
Cleared 510(K)
K
90
1175
HAND MIRROR
1
Cleared 510(K)
K
90
1174
ELEVATOR #11
1
Cleared 510(K)
K
90
1173
DISCOID SPOON EXCAVATOR
1
Cleared 510(K)
K
90
1172
GRACEY CURETTE #13-14
1
Cleared 510(K)
K
90
1171
U-15 SINGLE END SCALER
1
Cleared 510(K)
K
90
1170
PERIODONTAL KNIFE
1
Cleared 510(K)
K
90
1169
5 STRAIGHT SCISSORS
1
Cleared 510(K)
K
89
6843
EXPLORER 24 DENTAL HAND INSTRUMENT
1
Cleared 510(K)
K
89
6565
DMV(R) VENEER SUCTION GRIPPER
1
Cleared 510(K)
K
89
5985
SANI-PIKS DENTAL HAND INSTRUMENT
1
Cleared 510(K)
K
89
5958
BREVET FLOSS PICK (AUTOCLAVE STERILIZER)
1
Cleared 510(K)
K
89
5959
BREVET FLOSS PICK (COLD STERILIZATION FLUIDS)
1
Cleared 510(K)
K
89
4897
ANSWER DENTAL IMPLEMENT, FORCEPS
1
Cleared 510(K)
K
89
4895
ANSWER DENTAL IMPLEMENTS, MIRROR
1
Cleared 510(K)
K
89
4896
ANSWER DENTAL IMPLEMENT, EXPLORER
1
Cleared 510(K)
K
89
2239
DENTAL HAND INSTRUMENTS
1
Cleared 510(K)
K
89
2261
RUBBER DAM CLAMPS/FORCEPS
1
Cleared 510(K)
K
89
2260
PRICHARD PERIOSTEAL RETRACTOR #3
1
Cleared 510(K)
K
88
4308
MANDIBLE MANIPULATOR
1
Cleared 510(K)
K
89
0357
DENTAL IMPRESSION SYINGE
1
Cleared 510(K)
K
89
0064
DENTAL SYRINGE APPLICATION TIP
1
Cleared 510(K)
K
88
5218
DISCARD DENTAL MIRROR
1
Cleared 510(K)
K
88
5219
DENTAL DRESSING PLIERS
1
Cleared 510(K)
K
88
5217
DISCARD DENTAL EXPLORER
1
Cleared 510(K)
K
88
4653
RACESTYPTINE
1
Cleared 510(K)
K
88
5162
BENDA BRUSH
1
Cleared 510(K)
K
88
5040
DENTAL MIRROR RETRACTOR
1
Cleared 510(K)
K
88
4515
BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED
1
Cleared 510(K)
K
88
3126
BREVET DENTAL INSTRUMENTS
1
Cleared 510(K)
K
88
2821
VITRABOND LIGHT CURE GLASS IONOMER LINER
1
Cleared 510(K)
K
88
3322
DENTAL HAND INSTRUMENTS
1
Cleared 510(K)
K
88
2651
CENTRIX NEEDLETUBE
1
Cleared 510(K)
K
88
2834
TISSUE PUNCH
1
Cleared 510(K)
K
88
1992
SYRETTE
1
Cleared 510(K)
K
88
2309
THE DIRECTION DIAL
1
Cleared 510(K)
K
88
2399
ASEPTIP
1
Cleared 510(K)
K
88
0849
EXAMIX DISPENSER
1
Cleared 510(K)
K
88
0542
DENTALVISION TV SYSTEM
1
Cleared 510(K)
K
88
0590
DISPOSABLE DENTAL PROBE/EXPLORER
1
Cleared 510(K)
K
87
4964
DENTAL HAND INSTRUMENTS
1
Cleared 510(K)
K
87
4335
EXPLORER-DENTAL PROBER
1
Cleared 510(K)
K
82
1779
BEACH AMALGAM CARRIER, GUN TYPE
1
Cleared 510(K)
EKK
Spreader, Pulp Canal Filling Material, Endodontic
1
Product Code
EKP
Reamer, Pulp Canal, Endodontic
1
Product Code
EKQ
Preparer, Root Canal Endodontic
1
Product Code
EKR
Plugger, Root Canal, Endodontic
1
Product Code
EKS
File, Pulp Canal, Endodontic
1
Product Code
EKT
Curette, Endodontic
1
Product Code
EKW
Broach, Endodontic
1
Product Code
EKX
Handpiece, Direct Drive, Ac-Powered
1
Product Code
EKY
Handpiece, Water-Powered
1
Product Code
EKZ
Unit, Electrosurgical, And Accessories, Dental
2
Product Code
ELA
Instrument, Hand, Calculus Removal
1
Product Code
ELB
Scaler, Rotary
2
Product Code
ELC
Scaler, Ultrasonic
2
Product Code
EMD
Hemostat, Surgical
1
Product Code
EME
Punch, Biopsy, Surgical
1
Product Code
EMG
Forceps, Tooth Extractor, Surgical
1
Product Code
EMH
Forceps, Rongeur, Surgical
1
Product Code
EMI
File, Bone, Surgical
1
Product Code
EMJ
Elevator, Surgical, Dental
1
Product Code
EMK
Curette, Surgical, Dental
1
Product Code
EML
Chisel, Bone, Surgical
1
Product Code
EMM
Chisel, Osteotome, Surgical
1
Product Code
EMN
Scaler, Periodontic
1
Product Code
EMO
Knife, Periodontic
1
Product Code
EMP
Marker, Periodontic
1
Product Code
EMQ
Hoe, Periodontic
1
Product Code
EMR
File, Periodontic
1
Product Code
EMS
Curette, Periodontic
1
Product Code
JEP
Retainer, Matrix
1
Product Code
JEX
Plier, Orthodontic
1
Product Code
JEY
Plate, Bone
2
Product Code
KMW
Handpiece, Rotary Bone Cutting
2
Product Code
MDL
Implant, Transmandibular
2
Product Code
MQN
External Mandibular Fixator And/Or Distractor
2
Product Code
MXF
System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
2
Product Code
NEI
Prosthesis, Condyle, Mandibular, Temporary
2
Product Code
NLD
Instrument, Diamond, Dental, Reprocessed
1
Product Code
NMW
Needle, Dental, Reprocessed
1
Product Code
NYC
Dental Prophylaxis Kit
1
Product Code
NYF
Gingival Retraction Kit
1
Product Code
NYG
Lapping Tool Kit
1
Product Code
NYL
Handpiece, Air-Powered, Root Canal Irrigation
1
Product Code
PLV
Dental Stereotaxic Instrument
2
Product Code
PWL
Oral Surgery Tray
1
Product Code
NVK
Laser, Dental, Soft Tissue
2
Product Code
OAJ
Catheter, Drainage, Intraoral/Extraoral
1
Product Code
PEM
Dental Barriers And Sleeves
2
Product Code
QRY
Dental Navigation System
2
Product Code
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
Subpart G—Miscellaneous Devices
CFR Sub-Part
Ear, Nose, Throat
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Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
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Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
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Review Panel
Last synced on 20 June 2025 at 11:06 pm
DE
/
subpart-e—surgical-devices
/
EKJ
/
K912473
View Source
ACCU-PLACER TM KIT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K912473
510(k) Type
Traditional
Applicant
HU-FRIEDY MFG. CO.,INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/24/1991
Days to Decision
50 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
DZJ
Driver, Wire, And Bone Drill, Manual
DZK
Wire, Fixation, Intraosseous
DZL
Screw, Fixation, Intraosseous
DZM
Needle, Dental
DZN
Instruments, Dental Hand
DZP
Instrument, Diamond, Dental
DYX
Lock, Wire, And Ligature, Intraoral
DZA
Drill, Dental, Intraoral
DZH
Saw, Bone, Ac-Powered
DZI
Drill, Bone, Powered
EAX
Mirror, Mouth
EAY
Light, Fiber Optic, Dental
EAZ
Light, Operating, Dental
EBA
Light, Surgical Headlight
EBW
Controller, Foot, Handpiece And Cord
ECB
Unit, Syringe, Air And/Or Water
ECP
Instrument, Ligature Tucking, Orthodontic
ECQ
Aligner, Bracket, Orthodontic
ECR
Setter, Band, Orthodontic
ECS
Pusher, Band, Orthodontic
ECT
Driver, Band, Orthodontic
EFA
Handpiece, Belt And/Or Gear Driven, Dental
EFB
Handpiece, Air-Powered, Dental
EFK
Forceps, Articulation Paper
EFL
Forceps, Dressing, Dental
EGI
Parallelometer
EGM
Injector, Jet, Mechanical-Powered
EGN
Scissors, Surgical Tissue, Dental
EGQ
Injector, Jet, Gas-Powered
EGS
Handpiece, Contra- And Right-Angle Attachment, Dental
EIB
Syringe, Irrigating (Dental)
EIC
Syringe, Periodontic, Endodontic, Irrigating
EID
Syringe, Restorative And Impression Material
EIF
Accessories, Retractor, Dental
EIG
Retractor, All Types
EIK
Carver, Wax, Dental
EIL
Gauge, Depth, Instrument, Dental
EIR
Scissors, Collar And Crown
EIS
Remover, Crown
EIX
Probe, Periodontic
EIY
Instrument, Filling, Plastic, Dental
EJB
Handle, Instrument, Dental
EJY
Pliers, Operative
EJZ
Knife, Margin Finishing, Operative
EKA
File, Margin Finishing, Operative
EKB
Explorer, Operative
EKC
Excavator, Dental, Operative
EKD
Instrument, Cutting, Operative
EKE
Curette, Operative
EKF
Instrument, Contouring, Matrix, Operative
EKG
Condenser, Amalgam And Foil, Operative
EKH
Carver, Dental Amalgam, Operative
EKI
Carrier, Amalgam, Operative
EKJ
Burnisher, Operative
K
96
1714
ASEPTYLUM, UNI-CARRIER
K
95
3707
MEDTROL DENTAL KIT
K
94
5815
DENTAL KIT
K
95
1607
SUREFLEX FILES
K
94
5077
INSTRUMENT,FILLING,PLASTIC,DENTAL
K
94
3820
STAT PAK
K
94
3351
MAUNAL DISPOSABLE DENTAL INSTRUMENTS
K
94
3584
PRESTERILIZED ENDODONTIC FILES
K
93
5127
SOUTHLAND STERILE DENTAL SYSTEM
K
94
1954
NON-FOGGING DENTAL MIRROR
K
92
5115
AMD DENTIST AND HYGIENIST KITS
K
92
5890
MIRROR, MOUTH
K
92
5889
FORCEPS, DRESSING, DENTAL
K
92
5888
EXPLORER, OPERATIVE
K
93
5217
LC DENTAL HAND INSTRUMENT
K
93
2511
SILICONE MIRROR
K
92
6368
APPLICATOR NOZZLE
K
92
3902
STERILE DENTAL KITS
K
92
2988
ECO/DENTAL GENERAL DENTAL PACK
K
92
1354
BLUNT TIP IRRIGATION NEEDLES
K
91
4368
PART 872 DEGUFILL H & DEGUFILL M DA
K
91
1655
IMPLARETTE
K
91
2473
ACCU-PLACER TM KIT
K
91
1214
NUTIP (TM) SYRINGE SHIELD
K
91
2149
HARDCOATED PLASTIC FILLING INSTRUMENT
K
91
1281
PULPDENT PIC N STIC
K
90
1053
MIRROR SHIELD
K
90
1178
AMALGAM CONDENSER
K
90
1177
DISCOID/CLEOID DOUBLE END AMALGAM CARVER
K
90
1176
#23 EXPLORER
K
90
1175
HAND MIRROR
K
90
1174
ELEVATOR #11
K
90
1173
DISCOID SPOON EXCAVATOR
K
90
1172
GRACEY CURETTE #13-14
K
90
1171
U-15 SINGLE END SCALER
K
90
1170
PERIODONTAL KNIFE
K
90
1169
5 STRAIGHT SCISSORS
K
89
6843
EXPLORER 24 DENTAL HAND INSTRUMENT
K
89
6565
DMV(R) VENEER SUCTION GRIPPER
K
89
5985
SANI-PIKS DENTAL HAND INSTRUMENT
K
89
5958
BREVET FLOSS PICK (AUTOCLAVE STERILIZER)
K
89
5959
BREVET FLOSS PICK (COLD STERILIZATION FLUIDS)
K
89
4897
ANSWER DENTAL IMPLEMENT, FORCEPS
K
89
4895
ANSWER DENTAL IMPLEMENTS, MIRROR
K
89
4896
ANSWER DENTAL IMPLEMENT, EXPLORER
K
89
2239
DENTAL HAND INSTRUMENTS
K
89
2261
RUBBER DAM CLAMPS/FORCEPS
K
89
2260
PRICHARD PERIOSTEAL RETRACTOR #3
K
88
4308
MANDIBLE MANIPULATOR
K
89
0357
DENTAL IMPRESSION SYINGE
K
89
0064
DENTAL SYRINGE APPLICATION TIP
K
88
5218
DISCARD DENTAL MIRROR
K
88
5219
DENTAL DRESSING PLIERS
K
88
5217
DISCARD DENTAL EXPLORER
K
88
4653
RACESTYPTINE
K
88
5162
BENDA BRUSH
K
88
5040
DENTAL MIRROR RETRACTOR
K
88
4515
BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED
K
88
3126
BREVET DENTAL INSTRUMENTS
K
88
2821
VITRABOND LIGHT CURE GLASS IONOMER LINER
K
88
3322
DENTAL HAND INSTRUMENTS
K
88
2651
CENTRIX NEEDLETUBE
K
88
2834
TISSUE PUNCH
K
88
1992
SYRETTE
K
88
2309
THE DIRECTION DIAL
K
88
2399
ASEPTIP
K
88
0849
EXAMIX DISPENSER
K
88
0542
DENTALVISION TV SYSTEM
K
88
0590
DISPOSABLE DENTAL PROBE/EXPLORER
K
87
4964
DENTAL HAND INSTRUMENTS
K
87
4335
EXPLORER-DENTAL PROBER
K
82
1779
BEACH AMALGAM CARRIER, GUN TYPE
EKK
Spreader, Pulp Canal Filling Material, Endodontic
EKP
Reamer, Pulp Canal, Endodontic
EKQ
Preparer, Root Canal Endodontic
EKR
Plugger, Root Canal, Endodontic
EKS
File, Pulp Canal, Endodontic
EKT
Curette, Endodontic
EKW
Broach, Endodontic
EKX
Handpiece, Direct Drive, Ac-Powered
EKY
Handpiece, Water-Powered
EKZ
Unit, Electrosurgical, And Accessories, Dental
ELA
Instrument, Hand, Calculus Removal
ELB
Scaler, Rotary
ELC
Scaler, Ultrasonic
EMD
Hemostat, Surgical
EME
Punch, Biopsy, Surgical
EMG
Forceps, Tooth Extractor, Surgical
EMH
Forceps, Rongeur, Surgical
EMI
File, Bone, Surgical
EMJ
Elevator, Surgical, Dental
EMK
Curette, Surgical, Dental
EML
Chisel, Bone, Surgical
EMM
Chisel, Osteotome, Surgical
EMN
Scaler, Periodontic
EMO
Knife, Periodontic
EMP
Marker, Periodontic
EMQ
Hoe, Periodontic
EMR
File, Periodontic
EMS
Curette, Periodontic
JEP
Retainer, Matrix
JEX
Plier, Orthodontic
JEY
Plate, Bone
KMW
Handpiece, Rotary Bone Cutting
MDL
Implant, Transmandibular
MQN
External Mandibular Fixator And/Or Distractor
MXF
System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
NEI
Prosthesis, Condyle, Mandibular, Temporary
NLD
Instrument, Diamond, Dental, Reprocessed
NMW
Needle, Dental, Reprocessed
NYC
Dental Prophylaxis Kit
NYF
Gingival Retraction Kit
NYG
Lapping Tool Kit
NYL
Handpiece, Air-Powered, Root Canal Irrigation
PLV
Dental Stereotaxic Instrument
PWL
Oral Surgery Tray
NVK
Laser, Dental, Soft Tissue
OAJ
Catheter, Drainage, Intraoral/Extraoral
PEM
Dental Barriers And Sleeves
QRY
Dental Navigation System
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
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subpart-e—surgical-devices
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EKJ
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K912473
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ACCU-PLACER TM KIT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K912473
510(k) Type
Traditional
Applicant
HU-FRIEDY MFG. CO.,INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/24/1991
Days to Decision
50 days
Submission Type
Statement