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FDA 510(k) Application Details - K120937
Device Classification Name
Warmer, Infant Radiant
More FDA Info for this Device
510(K) Number
K120937
Device Name
Warmer, Infant Radiant
Applicant
ATOM MEDICAL CORPORATION
24301 WOODSAGE DRIVE
BONITA SPRINGS, FL 34134 US
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Contact
PAUL DRYDEN
Other 510(k) Applications for this Contact
Regulation Number
880.5130
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Classification Product Code
FMT
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More FDA Info for this Product Code
Date Received
03/28/2012
Decision Date
07/06/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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