510(k) K801585
- Device
- HESSBURG-BFRRON TREPHINE
- Applicant
- PRECISION INSTRUMENTS, INC.
- 510(k) number
- K801585
- Product code
- EMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-10-03
- Date received
- 1980-07-11
- Regulation
- 878.4800
- Classification name
- Knife, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- MI US
FDA Registration Numbers#
- 3004552850
- 9613083
- 3006561161
- 3002834291
- 3010692967
- 9611278
- 3005440795
- 1222773
- 9611503
- 3022320321
- 9611024
- 3031564283
- 9611112
- 3032391
- 3012995405
- 3013846070
- 3001297506
- 3008843439
- 3010667733
- 1057946
- 3004450489
- 3010399422
- 3004215117
- 3018318562
- 3003956316
- 2431166
- 3005528784
- 2028661
- 3004705187
- 9710524
- 3008338766
- 9614062
- 2242450
- 3000286616
- 3031231776
- 3007137643
- 3035678069
- 8040263
- 3005049358
- 1412854
- 3022862651
- 1043534
- 3016965929
- 1649518
- 3005092287
- 3003418325
- 3004892425
- 3005031160
- 3002090132
- 3008808049
- 8030607
- 2521877
- 3038718579
- 3008950755
- 3015895045
- 9680271
- 3007597038
- 3010353847
- 9612278
- 1055890
- 8010890
- 1066959
- 3005921503
- 3003244954
- 3002769835
- 9680002
- 3012226300
- 3012366928
- 3035708926
- 9610905
- 8043467
- 1421879
- 3009968482
- 3014268446
- 3027556548
- 3029901632
- 1018470
- 1056350
- 2245304
- 3008110533
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080133 | MOUNTABLE ENDOSCOPIC BLADE | A.M. Surgical, Inc. | 2008-03-13 |
| K982142 | MOUNTABLE ENDOSCOPIC KNIFE | A.M. Surgical, Inc. | 1998-12-30 |
| K890214 | MICROSURGERY RAZOR BLADE HOLDER | Kinetic Medical Products | 1989-01-27 |
| K890215 | MICROSURGICAL SCARIFIER | Kinetic Medical Products | 1989-01-27 |
| K890217 | MICROSURGICAL KNIVES | Kinetic Medical Products | 1989-01-27 |
| K880094 | VAN-TEC ENDOPYELOTOMY KNIFE | Van-Tec, Inc. | 1988-02-29 |
| K863752 | VALTRAC (BAR) REMOVER DEVICE | Davis & Geck, Inc. | 1986-10-24 |
| K863549 | REUSABLE/DISPOSABLE AUTOPSY KNIFE SET | Surgipath Medical Industries, Inc. | 1986-09-30 |
| K861947 | SURGICAL KNIFE | Sharpoint, Inc. | 1986-06-06 |
| K854891 | KNIFE | Euro-Med Intl. | 1986-05-02 |
| K851784 | 27-210 PLASTER KNIFE (REINER) | Artiberia | 1985-06-20 |
| K843497 | SURGICAL KNIVES & PROBES | Eder Instrument Co, Inc. | 1984-10-31 |
| K843371 | VALVOTOMY KNIFE | Downs Surgical , Ltd. | 1984-10-25 |
| K834184 | H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 | Imm Enterprises , Ltd. | 1984-01-27 |
| K834197 | JAKOBI SURG. INSTR- #11 38/39/45/46/67 | Imm Enterprises , Ltd. | 1984-01-27 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases