FDA 510(k) Application Details - K970196

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

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510(K) Number K970196
Device Name Tube, Tracheal (W/Wo Connector)
Applicant VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA, NJ 07512 US
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Contact ANTHONY P MARTINO
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 01/21/1997
Decision Date 08/21/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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