The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Esa Electrosurgical Arthroscopy Genera.
| Device ID | K830499 |
| 510k Number | K830499 |
| Device Name: | ESA ELECTROSURGICAL ARTHROSCOPY GENERA |
| Classification | Arthroscope |
| Applicant | CONCEPT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-16 |
| Decision Date | 1983-03-17 |