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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K063442
Device Name ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
Applicant
Degania Silicone , Ltd.
Degania Bet
Emek Hayarden,  IL 15130
Applicant Contact ZOYA LEE
Correspondent
Degania Silicone , Ltd.
Degania Bet
Emek Hayarden,  IL 15130
Correspondent Contact ZOYA LEE
Regulation Number876.5130
Classification Product Code
EZL  
Date Received11/14/2006
Decision Date 03/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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