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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 K955500
Device Name FMS ARTHOPROBE
Applicant
Future Medical Systems, Inc.
205 E. 63rd St.
Suite 7a
New York City,  NY  10021
Applicant Contact PATRICK JANIN
Correspondent
Future Medical Systems, Inc.
205 E. 63rd St.
Suite 7a
New York City,  NY  10021
Correspondent Contact PATRICK JANIN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received12/01/1995
Decision Date 02/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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