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FDA 510(k) Application Details - K971366
Device Classification Name
Warmer, Infant Radiant
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510(K) Number
K971366
Device Name
Warmer, Infant Radiant
Applicant
HILL-ROM, INC.
1069 STATE ROUTE 46 EAST
BATESVILLE, IN 47006 US
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Contact
JAMES G CARPENTER
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
04/14/1997
Decision Date
01/05/1998
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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