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#
- 3011164188
- 3003244954
- 9610612
- 3003334541
- 3019404837
- 3007123908
- 1720747
- 9616246
- 3004135030
- 8010273
- 3004450489
- 9611024
- 3007589150
- 8010547
- 8010298
- 3031564283
- 3005180920
- 3017352116
- 3035678069
- 3004892425
- 2244478
- 8043496
- 2521877
- 9612074
- 9613083
- 9680002
- 3018318562
- 9614069
- 3032747418
- 3002769835
- 3031231776
- 3011600579
- 2084346
- 3011529314
- 3011137372
- 1222773
- 1313525
- 3015972835
- 3008808049
- 3009703496
- 8040278
- 3003956316
- 9681622
- 9611503
- 3003407244
- 3010667733
- 3010834934
- 3015512299
- 1058726
- 3013946322
- 2434839
- 2919128
- 3002090132
- 2028661
- 3048101437
- 3032391
- 3006142527
- 3007773213
- 3007137643
- 1417592
- 9680718
- 3010155661
- 1424434
- 8040233
- 1018470
- 9611112
- 3009499159
- 3012366928
- 3005440795
- 3036795921
- 1820334
- 3013784566
- 3010055973
- 8010372
- 3009968482
- 3010202439
- 3012185136
- 2242450
- 3007887711
- 1058584
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