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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tourniquet, Nonpneumatic
510(k) Number K931198
Device Name UNIQUET
Applicant
Icat Systems
16303 Panoramic Way
San Leandro,  CA  94578
Applicant Contact GARY ALLSEBROOK
Correspondent
Icat Systems
16303 Panoramic Way
San Leandro,  CA  94578
Correspondent Contact GARY ALLSEBROOK
Regulation Number878.5900
Classification Product Code
GAX  
Date Received03/09/1993
Decision Date 09/01/1993
Decision Substantially Equivalent (SESE)
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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