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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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