FDA 510(k) Application Details - K153518

Device Classification Name Cylinder, Compressed Gas, And Valve

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510(K) Number K153518
Device Name Cylinder, Compressed Gas, And Valve
Applicant PRAXAIR DISTRIBUTION, INCORPORATED.
175 EAST PARK DRIVE
TONAWANDA, NY 14150 US
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Contact Michael Skrjanc
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Regulation Number 000.0000

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Classification Product Code ECX
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Date Received 12/08/2015
Decision Date 06/03/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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