FDA 510(k) Application Details - K040657

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

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510(K) Number K040657
Device Name Tube, Tracheal (W/Wo Connector)
Applicant VYGON S A
45900 PARSIPPANY COURT
TEMECULA, CA 92592 US
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Contact LAETITIA BERNARD
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 03/12/2004
Decision Date 06/10/2004
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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