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FDA 510(k) Application Details - K040853
Device Classification Name
Unit, Neonatal Phototherapy
More FDA Info for this Device
510(K) Number
K040853
Device Name
Unit, Neonatal Phototherapy
Applicant
INTERNATIONAL HOSPITAL SUPPLY CO.
AMSTEL 320-1
AMSTERDAM 1017AP NL
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Contact
ANGELIKA SCHERP
Other 510(k) Applications for this Contact
Regulation Number
880.5700
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Classification Product Code
LBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/01/2004
Decision Date
06/21/2004
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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