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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Neonatal Phototherapy
510(k) Number K120168
Device Name LULLABY LED PHOTTHERAPY SYSTEM
Applicant
Wipro GE Healthcare Private, Ltd.
8880 Gorman Rd.
Laurel,  MD  20723
Applicant Contact AGATA ANTHONY
Correspondent
Wipro GE Healthcare Private, Ltd.
8880 Gorman Rd.
Laurel,  MD  20723
Correspondent Contact AGATA ANTHONY
Regulation Number880.5700
Classification Product Code
LBI  
Date Received01/19/2012
Decision Date 05/02/2012
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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