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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 K161413
Device Name Low Profile Balloon Feeding Device
Applicant
Applied Medical Technology, Inc.
8006 Katherine Blvd.
Brecksville,  OH  44141
Applicant Contact Michelle Scott
Correspondent
Applied Medical Technology, Inc.
8006 Katherine Blvd.
Brecksville,  OH  44141
Correspondent Contact Michelle Scott
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/23/2016
Decision Date 02/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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