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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name warmer, infant radiant
510(k) Number K121625
Device Name LULLABY TM WARMER
Original Applicant
WIPRO GE HEALTHCARE PRIVATE, LTD.
8880 goman road
laurel,  MD  20723 -5800
Original Contact agata anthony
Regulation Number880.5130
Classification Product Code
FMT  
Date Received06/01/2012
Decision Date 09/14/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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