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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K053120
FOIA Releasable 510(k) K053120
Device Name STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
Applicant
EXCELSIOR MEDICAL CORP.
1923 HECK AVE.
NEPTUNE,  NJ  07753
Applicant Contact RUBEN MARTINEZ
Correspondent
EXCELSIOR MEDICAL CORP.
1923 HECK AVE.
NEPTUNE,  NJ  07753
Correspondent Contact RUBEN MARTINEZ
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/07/2005
Decision Date 12/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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