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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Depressor, Orbital
510(k) Number K951702
Device Name FMS HIGH FLOW ARTHRO-SHEATH
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 Number886.4350
Classification Product Code
HNX  
Date Received04/12/1995
Decision Date 05/12/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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