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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 K142971
Device Name AMT Bridle - Nasal Tube Retention System
Applicant
Applied Medical Technology, Inc.
8000 Katherine Blvd.
Brecksville,  OH  44141
Applicant Contact Joshua Meinke
Correspondent
Applied Medical Technology, Inc.
8000 Katherine Blvd.
Brecksville,  OH  44141
Correspondent Contact Joshua Meinke
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/14/2014
Decision Date 05/26/2015
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
Recalls CDRH Recalls
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