ARTHRO FMS 4

Arthroscope

ORTHOCONCEPT, INC.

The following data is part of a premarket notification filed by Orthoconcept, Inc. with the FDA for Arthro Fms 4.

Pre-market Notification Details

Device IDK925160
510k NumberK925160
Device Name:ARTHRO FMS 4
ClassificationArthroscope
Applicant ORTHOCONCEPT, INC. 205 EAST 63RD ST. SUITE 7A New York City,  NY  10021
ContactPatrick Janin
CorrespondentPatrick Janin
ORTHOCONCEPT, INC. 205 EAST 63RD ST. SUITE 7A New York City,  NY  10021
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-13
Decision Date1994-02-17

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