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FDA 510(k) Application Details - K100285
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K100285
Device Name
Nebulizer (Direct Patient Interface)
Applicant
RESPIRONICS NEW JERSEY, INC.
5 WOOD HOLLOW ROAD
PARSIPPANY, NJ 07054 US
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Contact
Lauren Ziegler
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Regulation Number
868.5630
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Classification Product Code
CAF
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More FDA Info for this Product Code
Date Received
02/01/2010
Decision Date
06/29/2010
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
Y
Expedited Review
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