FDA 510(k) Application Details - K021044

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

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510(K) Number K021044
Device Name Tube, Tracheal (W/Wo Connector)
Applicant WOLFE TORY MEDICAL, INC.
79 WEST 4500 SOUTH, SUITE 16
SALT LAKE CITY, UT 84107 US
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Contact TIM WOLFE
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 04/01/2002
Decision Date 09/11/2002
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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