510(k) K780989
- Device
- DEVIN-NESTOR SQUARE KNIFE
- Applicant
- NESTOR ENGINEERING ASSOCIATES, INC.
- 510(k) number
- K780989
- Product code
- EMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-10-03
- Date received
- 1978-06-14
- 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
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007123908
- 3005921503
- 9611112
- 3038718579
- 3005440795
- 2245304
- 8010372
- 3004215117
- 2249529
- 8043507
- 2431166
- 9615857
- 3006059835
- 1421879
- 1056350
- 3009703496
- 3032391
- 3004892425
- 9611024
- 8040278
- 3002090132
- 8010099
- 3010041511
- 3035678069
- 3007589150
- 1923569
- 2134752
- 3014615697
- 1066959
- 3008338766
- 2242450
- 8040263
- 9611283
- 3004193466
- 9613926
- 3005031160
- 3007597038
- 3004598675
- 8040881
- 3010399422
- 9681161
- 3010055973
- 1313525
- 3006142527
- 3003244954
- 8010159
- 8043816
- 3009340886
- 3015895045
- 8040179
- 3018821071
- 3008808049
- 3002862271
- 3002808270
- 3001297506
- 3027556548
- 3004450489
- 3015972835
- 3029901632
- 1424434
- 2437731
- 3012267976
- 3013946322
- 3018318562
- 9680271
- 3010667733
- 1836161
- 3023155873
- 3025376090
- 3029082594
- 3035708926
- 3031231776
- 9680515
- 2436906
- 3003956316
- 2919128
- 1018470
- 2529846
- 3005092287
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 |
| K890217 | MICROSURGICAL KNIVES | Kinetic Medical Products | 1989-01-27 |
| K890215 | MICROSURGICAL SCARIFIER | Kinetic Medical Products | 1989-01-27 |
| K890214 | MICROSURGERY RAZOR BLADE HOLDER | 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 |
| K834197 | JAKOBI SURG. INSTR- #11 38/39/45/46/67 | Imm Enterprises , Ltd. | 1984-01-27 |
| K834184 | H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 | 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