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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Tracheal Tube
510(k) Number K140097
Device Name AMT ENDOTRACHEAL TUBE BRIDLE 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 Number868.5770
Classification Product Code
CBH  
Date Received01/14/2014
Decision Date 09/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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