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FDA 510(k) Application Details - K012229
Device Classification Name
Warmer, Infant Radiant
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510(K) Number
K012229
Device Name
Warmer, Infant Radiant
Applicant
NATIONAL CUSTOM ENT., INC.
1133 EAST CLIFF RD.
BURNSVILLE, MN 55337 US
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Contact
DON PELLETIER
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
07/16/2001
Decision Date
09/10/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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