FDA 510(k) Application Details - K984528

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

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510(K) Number K984528
Device Name Tube, Tracheal (W/Wo Connector)
Applicant PARKER MEDICAL ASSOC.
109 INVERNESS DRIVE EAST,
SUITE J
ENGLEWOOD, CO 80112-5105 US
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Contact JEFFREY D PARKER
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 12/21/1998
Decision Date 07/15/1999
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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