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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 K050785
Device Name AMSINO ENDOTRACHEAL TUBE
Applicant
Amsino International, Inc.
855 Towne Center Dr.
Pomona,  CA  91767
Applicant Contact CHING CHING SEAH
Correspondent
Amsino International, Inc.
855 Towne Center Dr.
Pomona,  CA  91767
Correspondent Contact CHING CHING SEAH
Regulation Number868.5730
Classification Product Code
BTR  
Date Received03/28/2005
Decision Date 07/15/2005
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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