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
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Regulation Number 880.5130

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Classification Product Code FMT
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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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