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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 K133446
Device Name HEPARIN LOCK / FLUSH SYRINGES
Applicant
Excelsior Medical Corporation
1933 HECK AVE
NEPTUNE,  NJ  07753
Applicant Contact JOHN LINFANTE
Correspondent
Excelsior Medical Corporation
1933 HECK AVE
NEPTUNE,  NJ  07753
Correspondent Contact JOHN LINFANTE
Regulation Number880.5200
Classification Product Code
NZW  
Date Received11/12/2013
Decision Date 11/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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