The following data is part of a premarket notification filed by Intramed Laboratories, Inc. with the FDA for Flexible Arthroscope.
| Device ID | K904465 |
| 510k Number | K904465 |
| Device Name: | FLEXIBLE ARTHROSCOPE |
| Classification | Arthroscope |
| Applicant | INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Contact | Alden Kay |
| Correspondent | Alden Kay INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-01 |
| Decision Date | 1990-12-20 |