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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
Israel,  IL 15130
Applicant Contact ZOYA LEE
Correspondent
Degania Silicone , Ltd.
Kibbutz Degania Bet
Israel,  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
Predetermined Change
Control Plan Authorized		 No
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