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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 K123716
Device Name AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT
Applicant
APPLIED MEDICAL TECHNOLOGY, INC.
8000 KATHERINE BOULEVARD
BRECKSVILLE,  OH  44141
Applicant Contact GRANT W PHILLIPS
Correspondent
APPLIED MEDICAL TECHNOLOGY, INC.
8000 KATHERINE BOULEVARD
BRECKSVILLE,  OH  44141
Correspondent Contact GRANT W PHILLIPS
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/04/2012
Decision Date 04/19/2013
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
Recalls CDRH Recalls
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