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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
Applicant
APPLIED MEDICAL TECHNOLOGY, INC.
8000 KATHERINE BOULEVARD
BRECKSVILLE,  OH  44141
Applicant Contact ELIZABETH MEYER
Correspondent
APPLIED MEDICAL TECHNOLOGY, INC.
8000 KATHERINE BOULEVARD
BRECKSVILLE,  OH  44141
Correspondent 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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