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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K031794
Device Name ENDOFLEX TRACHEAL TUBE
Applicant
Merlyn Associates, Inc.
Amsino International Inc.
4501 Brickell Privado
Ontario,  CA  91761
Applicant Contact CHING CHING SEAH, PH.D.
Correspondent
Merlyn Associates, Inc.
Amsino International Inc.
4501 Brickell Privado
Ontario,  CA  91761
Correspondent Contact CHING CHING SEAH, PH.D.
Regulation Number868.5730
Classification Product Code
BTR  
Date Received06/10/2003
Decision Date 03/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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