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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name arthroscope
510(k) Number K954465
Device Name FMS DUO
Applicant
FUTURE MEDICAL SYSTEMS, INC.
205 EAST 63RD ST.
SUITE 7A
NEW YORK CITY,  NY  10021
Applicant Contact PATRICK JANIN
Correspondent
FUTURE MEDICAL SYSTEMS, INC.
205 EAST 63RD ST.
SUITE 7A
NEW YORK CITY,  NY  10021
Correspondent Contact PATRICK JANIN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/25/1995
Decision Date 11/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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