The following data is part of a premarket notification filed by Orthoconcept, Inc. with the FDA for Arthro Fms 4.
Device ID | K925160 |
510k Number | K925160 |
Device Name: | ARTHRO FMS 4 |
Classification | Arthroscope |
Applicant | ORTHOCONCEPT, INC. 205 EAST 63RD ST. SUITE 7A New York City, NY 10021 |
Contact | Patrick Janin |
Correspondent | Patrick Janin ORTHOCONCEPT, 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 | 1992-10-13 |
Decision Date | 1994-02-17 |