FDA 510(k) Application Details - K031794

Device Classification Name Tube, Tracheal (W/Wo Connector)

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510(K) Number K031794
Device Name Tube, Tracheal (W/Wo Connector)
Applicant MERLYN ASSOCIATES INC.
AMSINO INTERNATIONAL INC.
4501 BRICKELL PRIVADO
ONTARIO, CA 91761 US
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Contact CHING CHING SEAH, PH.D.
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 06/10/2003
Decision Date 03/12/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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