FMS ARTHRO-CUTTER

Depressor, Orbital

FUTURE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Future Medical Systems, Inc. with the FDA for Fms Arthro-cutter.

Pre-market Notification Details

Device IDK951701
510k NumberK951701
Device Name:FMS ARTHRO-CUTTER
ClassificationDepressor, Orbital
Applicant FUTURE MEDICAL SYSTEMS, INC. 205 EAST 63RD ST. SUITE 7A New York City,  NY  10021
ContactPatrick Janin
CorrespondentPatrick Janin
FUTURE MEDICAL SYSTEMS, INC. 205 EAST 63RD ST. SUITE 7A New York City,  NY  10021
Product CodeHNX  
CFR Regulation Number886.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-12
Decision Date1995-05-09

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