The following data is part of a premarket notification filed by Future Medical Systems, Inc. with the FDA for Fms High Flow Arthro-sheath.
| Device ID | K951702 |
| 510k Number | K951702 |
| Device Name: | FMS HIGH FLOW ARTHRO-SHEATH |
| Classification | Depressor, Orbital |
| 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 | HNX |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-12 |
| Decision Date | 1995-05-12 |