FDA 510(k) Application Details - K091761

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

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510(K) Number K091761
Device Name Tube, Tracheal (W/Wo Connector)
Applicant Teleflex Medical, Inc.
2917 WECK DR.
RESEARCH TRIANGLE PARK, NC 27709 US
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Contact WILLIAM HEARD
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 06/16/2009
Decision Date 10/29/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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