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 |