FDA 510(k) Application Details - K073702

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

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510(K) Number K073702
Device Name Tube, Tracheostomy (W/Wo Connector)
Applicant LAZARUS MEDICAL LLC
2129 BENEVENTUM CT
RALEIGH, NC 27606 US
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Contact CYNTHIA J.M NOLTE
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Regulation Number 868.5800

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Classification Product Code BTO
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Date Received 12/31/2007
Decision Date 06/26/2008
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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