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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
Model 1030
Device Name LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
Applicant
DEGANIA SILICONE, LTD.
kibbutz degania bet
emek hayarden, 
Contact zoya lee
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/11/2012
Decision Date 09/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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