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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K910816
Device Name IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE
Applicant
Insight International, Inc.
500 Prospect St.
Pawtucket,  RI  02860
Applicant Contact PHILLIP F JANES
Correspondent
Insight International, Inc.
500 Prospect St.
Pawtucket,  RI  02860
Correspondent Contact PHILLIP F JANES
Regulation Number878.4800
Classification Product Code
KDD  
Date Received02/26/1991
Decision Date 04/17/1991
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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