FDA 510(k) Application Details - K082520

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

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510(K) Number K082520
Device Name Tube, Tracheal (W/Wo Connector)
Applicant MALLINCKRODT MEDICAL
6135 GUNBARREL AVE.
BOULDER, CO 80301 US
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Contact SCOTT D DICKERHOFF
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 09/02/2008
Decision Date 10/02/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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