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FDA 510(k) Application Details - K033040
Device Classification Name
Warmer, Infant Radiant
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510(K) Number
K033040
Device Name
Warmer, Infant Radiant
Applicant
INTERNATIONAL HOSPITAL SUPPLY CO.
AMSTEL 320-1
AMSTERDAM 1017AP NL
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Contact
DAGMAR MASER
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
09/29/2003
Decision Date
12/17/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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