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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 K120937
Device Name SUNFLOWER WARNER
Original Applicant
ATOM MEDICAL CORPORATION
24301 woodsage drive
bonita springs,  FL  34134
Original Contact paul dryden
Regulation Number880.5130
Classification Product Code
FMT  
Date Received03/28/2012
Decision Date 07/06/2012
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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