FDA 510(k) Application Details - K030570

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

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510(K) Number K030570
Device Name Tube, Tracheostomy (W/Wo Connector)
Applicant PORTEX LTD.
MILITARY ROAD
HYTH, KENT CT21 6DB GB
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Contact STEVE OGILVIE
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Regulation Number 868.5800

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Classification Product Code BTO
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Date Received 02/24/2003
Decision Date 09/17/2003
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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