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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 K131020
Device Name TEMPERATURE SENSOR CATHETER
Applicant
DEGANIA SILICONE, LTD.
KIBBUTZ DEGANIA BET
ISRAEL,  IL 15130
Applicant Contact ZOYA LEE
Correspondent
DEGANIA SILICONE, LTD.
KIBBUTZ DEGANIA BET
ISRAEL,  IL 15130
Correspondent Contact ZOYA LEE
Regulation Number876.5130
Classification Product Code
EZL  
Date Received04/12/2013
Decision Date 05/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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