The following data is part of a premarket notification filed by Optus, Inc. with the FDA for Optus Arthroscope & Mini-arthroscope Accessories.
| Device ID | K953913 |
| 510k Number | K953913 |
| Device Name: | OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES |
| Classification | Arthroscope |
| Applicant | OPTUS, INC. 1200 SOUTH PARKER RD. Denver, CO 80231 |
| Contact | Peter Duffy |
| Correspondent | Peter Duffy OPTUS, INC. 1200 SOUTH PARKER RD. Denver, CO 80231 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-21 |
| Decision Date | 1996-01-22 |