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FDA 510(k) Application Details - K023740
Device Classification Name
Heparin, Vascular Access Flush
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510(K) Number
K023740
Device Name
Heparin, Vascular Access Flush
Applicant
EXCELSIOR MEDICAL CORP.
1923 HECK AVE.
NEPTUNE, NJ 07753 US
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DAVID LUMIA
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Regulation Number
880.5200
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Classification Product Code
NZW
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More FDA Info for this Product Code
Date Received
11/07/2002
Decision Date
05/13/2003
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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