FDA 510(k) Application Details - K081086

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

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510(K) Number K081086
Device Name Tube, Tracheal (W/Wo Connector)
Applicant SMITHS MEDICAL ASD, INC.
MILITARY ROAD
HYTHE, KENT CT216JL GB
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Contact JOHN TULLETT
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 04/16/2008
Decision Date 08/13/2008
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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