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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Fluid Delivery
510(k) Number K953864
Device Name SILCLEAR TUBING (MODIFICATION)
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 Number880.5440
Classification Product Code
FPK  
Date Received08/07/1995
Decision Date 11/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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