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FDA 510(k) Application Details - K110293
Device Classification Name
Holding Chambers, Direct Patient Interface
More FDA Info for this Device
510(K) Number
K110293
Device Name
Holding Chambers, Direct Patient Interface
Applicant
RESPIRONICS NEW JERSEY, INC.
5 WOOD HOLLOW ROAD
PARSIPPANY, NJ 07054 US
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Contact
Lauren Ziegler
Other 510(k) Applications for this Contact
Regulation Number
868.5630
More FDA Info for this Regulation Number
Classification Product Code
NVP
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More FDA Info for this Product Code
Date Received
02/01/2011
Decision Date
08/09/2011
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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