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FDA 510(k) Application Details - K153518
Device Classification Name
Cylinder, Compressed Gas, And Valve
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
ECX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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