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FDA 510(k) Application Details - K200319
Device Classification Name
Warmer, Infant Radiant
More FDA Info for this Device
510(K) Number
K200319
Device Name
Warmer, Infant Radiant
Applicant
DeRoyal Industries, Inc.
200 DeBusk Lane
Powell, TN 37849 US
Other 510(k) Applications for this Company
Contact
Sarah Bennett
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
02/07/2020
Decision Date
04/02/2020
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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