FDA 510(k) Application Details - K954585

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

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510(K) Number K954585
Device Name Tube, Tracheal (W/Wo Connector)
Applicant RUSCH INTL.
TALL PINES PARK
JAFFREY, NH 03452 US
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Contact NEIL R ARMSTRONG
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 10/02/1995
Decision Date 05/10/1996
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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