FDA 510(k) Application Details - K073383

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

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510(K) Number K073383
Device Name Tube, Tracheal (W/Wo Connector)
Applicant WELL LEAD MEDICAL INSTRUMENTS
962 ALLERGO LANE
APOLLO BEACH, FL 33572 US
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Contact ARTHUR J WARD
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 12/03/2007
Decision Date 07/10/2008
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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