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FDA 510(k) Application Details - K963058
Device Classification Name
Warmer, Infant Radiant
More FDA Info for this Device
510(K) Number
K963058
Device Name
Warmer, Infant Radiant
Applicant
OHMEDA MEDICAL
9065 GUILFORD RD.
COLUMBIA, MD 21046 US
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Contact
ALBERTO F PROFUMO
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
08/06/1996
Decision Date
10/01/1996
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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