The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Arthroscope & Accessories.
| Device ID | K921985 |
| 510k Number | K921985 |
| Device Name: | ARTHROSCOPE & ACCESSORIES |
| Classification | Arthroscope |
| Applicant | OPTIMED TECHNOLOGIES, INC. 1441 N. BATAVIA STREETT, SUITE 114 Orange, CA 92667 |
| Contact | Ronald J Ehmsen |
| Correspondent | Ronald J Ehmsen OPTIMED TECHNOLOGIES, INC. 1441 N. BATAVIA STREETT, SUITE 114 Orange, CA 92667 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-28 |
| Decision Date | 1993-06-29 |