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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tube, gastro-enterostomy
510(k) Number K120587
Device Name AMT T-FASTENER ANCHOR KIT
Original Applicant
APPLIED MEDICAL TECHNOLOGY, INC.
8000 katherine boulevard
brecksville,  OH  44141
Original Contact elizabeth meyer
Regulation Number876.5980
Classification Product Code
KGC  
Date Received02/27/2012
Decision Date 05/25/2012
Decision substantially equivalent - kit (SESK)
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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