The following data is part of a premarket notification filed by Intramed Laboratories, Inc. with the FDA for Arthroscope.
| Device ID | K931792 |
| 510k Number | K931792 |
| Device Name: | ARTHROSCOPE |
| Classification | Trephine, Manual, Ophthalmic |
| Applicant | INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Contact | Stephen Sosnowski |
| Correspondent | Stephen Sosnowski INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Product Code | HRH |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-12 |
| Decision Date | 1994-06-13 |