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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K122030
Device Name LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
Applicant
DEGANIA SILICONE, LTD.
KIBBUTZ DEGANIA BET
EMEK HAYARDEN,  IL 15130
Applicant Contact ZOYA LEE
Correspondent
DEGANIA SILICONE, LTD.
KIBBUTZ DEGANIA BET
EMEK HAYARDEN,  IL 15130
Correspondent Contact ZOYA LEE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/11/2012
Decision Date 09/05/2012
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
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