The following data is part of a premarket notification filed by Olsen Electro-surgical Instruments, Inc. with the FDA for Olsen 756 Rocker Switchpen.
| Device ID | K834329 |
| 510k Number | K834329 |
| Device Name: | OLSEN 756 ROCKER SWITCHPEN |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLSEN ELECTRO-SURGICAL INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-12 |
| Decision Date | 1984-04-04 |