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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heparin, Vascular Access Flush
510(k) Number K023740
Device Name SYREX PRE-FILLED SYRINGE
Applicant
EXCELSIOR MEDICAL CORP.
1923 HECK AVE.
NEPTUNE,  NJ  07753
Applicant Contact DAVID LUMIA
Correspondent
EXCELSIOR MEDICAL CORP.
1923 HECK AVE.
NEPTUNE,  NJ  07753
Correspondent Contact DAVID LUMIA
Regulation Number880.5200
Classification Product Code
NZW  
Date Received11/07/2002
Decision Date 05/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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