The following data is part of a premarket notification filed by Future Medical Systems, Inc. with the FDA for Arthroplast & Arthro-cutter.
| Device ID | K954217 |
| 510k Number | K954217 |
| Device Name: | ARTHROPLAST & ARTHRO-CUTTER |
| Classification | Arthroscope |
| Applicant | FUTURE MEDICAL SYSTEMS, INC. 205 EAST 63RD ST. SUITE 7A New York City, NY 10021 |
| Contact | Patrick Janin |
| Correspondent | Patrick Janin FUTURE MEDICAL SYSTEMS, INC. 205 EAST 63RD ST. SUITE 7A New York City, NY 10021 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-08 |
| Decision Date | 1995-10-23 |