The following data is part of a premarket notification filed by Orthopedic Sciences, Inc with the FDA for Arthroscope.
| Device ID | K091398 |
| 510k Number | K091398 |
| Device Name: | ARTHROSCOPE |
| Classification | Arthroscope |
| Applicant | ORTHOPEDIC SCIENCES, INC 3020 OLD RANCH PARKWAY SUITE 325 Seal Beach, CA 90740 |
| Contact | James K Brannon |
| Correspondent | James K Brannon ORTHOPEDIC SCIENCES, INC 3020 OLD RANCH PARKWAY SUITE 325 Seal Beach, CA 90740 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-12 |
| Decision Date | 2009-08-26 |