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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 K183508
Device Name Micro Transgastric-Jejunal Feeding Device
Applicant
Applied Medical Technology, Inc.
8006 Katherine Boulevard
Brecksville,  OH  44141
Applicant Contact Joy Tubero
Correspondent
Applied Medical Technology, Inc.
8006 Katherine Boulevard
Brecksville,  OH  44141
Correspondent Contact Joy Tubero
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/18/2018
Decision Date 03/29/2019
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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