FDA 510(k) Application Details - K120985

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

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510(K) Number K120985
Device Name Tube, Tracheal (W/Wo Connector)
Applicant KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL, GA 30076 US
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Contact MARCIA JOHNSON
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 04/02/2012
Decision Date 12/19/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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