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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
Models 2050878-001, 2061755-001
Device Name LULLABY TM WARMER
Applicant
WIPRO GE HEALTHCARE PRIVATE, LTD.
8880 goman road
laurel,  MD  20723 5800
Contact agata anthony
Regulation Number880.5130
Classification Product Code
FMT  
Date Received06/01/2012
Decision Date 09/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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