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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Contact DAVID LUMIA
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Regulation Number 880.5200

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Classification Product Code NZW
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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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