The following data is part of a premarket notification filed by Future Medical Systems, Inc. with the FDA for Fms Arthroscopy Cannula.
Device ID | K945973 |
510k Number | K945973 |
Device Name: | FMS ARTHROSCOPY CANNULA |
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 | 1994-12-08 |
Decision Date | 1995-03-22 |