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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 K875092
Device Name DEGANIA SILICONE TOURNIQUET
Applicant
Degania Silicone , Ltd.
Degania Bet
Emek Hayarden,  IL 15130
Applicant Contact BETTE LUBIN
Correspondent
Degania Silicone , Ltd.
Degania Bet
Emek Hayarden,  IL 15130
Correspondent Contact BETTE LUBIN
Regulation Number878.5900
Classification Product Code
GAX  
Date Received12/10/1987
Decision Date 01/07/1988
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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