The following data is part of a premarket notification filed by Tecno Instruments (usa), Inc. with the FDA for Tecno Reusable, Electrosurgical, Bipolar Forceps.
| Device ID | K964176 |
| 510k Number | K964176 |
| Device Name: | TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | TECNO INSTRUMENTS (USA), INC. P.O. BOX 991251 Louville, KY 40269 |
| Contact | Michael Janocik |
| Correspondent | Michael Janocik TECNO INSTRUMENTS (USA), INC. P.O. BOX 991251 Louville, KY 40269 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-18 |
| Decision Date | 1997-08-14 |