FDA 510(k) Application Details - K060094

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

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510(K) Number K060094
Device Name Tube, Tracheal (W/Wo Connector)
Applicant ARCADIA MEDICAL CORPORATION
1450 EAST AMERICAN LANE
SUITE 1400
SCHAUMBURG, IL 60173 US
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Contact MARK FOOTE
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 01/12/2006
Decision Date 05/08/2006
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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