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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
Applicant
WIPRO GE HEALTHCARE PRIVATE, LTD.
8880 GOMAN ROAD
LAUREL,  MD  20723 -5800
Applicant Contact AGATA ANTHONY
Correspondent
WIPRO GE HEALTHCARE PRIVATE, LTD.
8880 GOMAN ROAD
LAUREL,  MD  20723 -5800
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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