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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 K222846
Device Name AMT G-Tube Balloon Gastrostomy Feeding Device
Applicant
Applied Medical Technology, Inc.
8006 Katherine Blvd.
Brecksville,  OH  44141
Applicant Contact Jennifer Hazou
Correspondent
Applied Medical Technology, Inc.
8006 Katherine Blvd.
Brecksville,  OH  44141
Correspondent Contact Jennifer Hazou
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/21/2022
Decision Date 12/18/2023
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
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