The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Electro Surgery System.
| Device ID | K841165 |
| 510k Number | K841165 |
| Device Name: | ELECTRO SURGERY SYSTEM |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-19 |
| Decision Date | 1984-06-05 |