FDA 510(k) Application Details - K973191

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

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510(K) Number K973191
Device Name Tube, Tracheal (W/Wo Connector)
Applicant PULMONX
1047 ELWELL COURT
PALO ALTO, CA 94303 US
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Contact ROBERT KOTMEL
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 08/25/1997
Decision Date 02/13/1998
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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