FDA 510(k) Application Details - K141747

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

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510(K) Number K141747
Device Name Tube, Tracheal (W/Wo Connector)
Applicant DAVIS MEDICAL
12602 N. SUMMER WIND DRIVE
MARANA, AZ 85658 US
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Contact MICHELLE LOTT
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 06/30/2014
Decision Date 04/20/2015
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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