The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Bi-tec Endoscopic Bipolar Instruments.
| Device ID | K942077 |
| 510k Number | K942077 |
| Device Name: | BI-TEC ENDOSCOPIC BIPOLAR INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Carol A Weideman, Ph.d |
| Correspondent | Carol A Weideman, Ph.d LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-29 |
| Decision Date | 1994-11-14 |