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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holding Chambers, Direct Patient Interface
510(k) Number K110293
Device Name OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER
Applicant
RESPIRONICS NEW JERSEY, INC.
5 WOOD HOLLOW ROAD
PARSIPPANY,  NJ  07054
Applicant Contact Lauren Ziegler
Correspondent
RESPIRONICS NEW JERSEY, INC.
5 WOOD HOLLOW ROAD
PARSIPPANY,  NJ  07054
Correspondent Contact Lauren Ziegler
Regulation Number868.5630
Classification Product Code
NVP  
Date Received02/01/2011
Decision Date 08/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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