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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K100285
Device Name LITETOUCH MASK
Applicant
RESPIRONICS NEW JERSEY, INC.
5 WOOD HOLLOW ROAD
PARSIPPANY,  NJ  07054
Applicant Contact Lauren Ziegler
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/01/2010
Decision Date 06/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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