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FDA 510(k) Application Details - K070377
Device Classification Name
Warmer, Infant Radiant
More FDA Info for this Device
510(K) Number
K070377
Device Name
Warmer, Infant Radiant
Applicant
OHMEDA MEDICAL
8880 GORMAN RD.
LAUREL, MD 20723 US
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Contact
AGATA SMIEJA
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
02/08/2007
Decision Date
07/11/2007
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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