FDA 510(k) Application Details - K150603

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

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510(K) Number K150603
Device Name Tube, Tracheal (W/Wo Connector)
Applicant Teleflex Medical, Inc.
2917 Weck Drive
Research Triangle Park, NC 27709 US
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Contact Lori Pfohl
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 03/10/2015
Decision Date 11/27/2015
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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