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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saline, Vascular Access Flush
510(k) Number K082837
Device Name STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
Applicant
Excelsior Medical Corp.
1933 Heck Ave.
Neptune,  NJ  07753
Applicant Contact JOHN LINFANTE
Correspondent
Excelsior Medical Corp.
1933 Heck Ave.
Neptune,  NJ  07753
Correspondent Contact JOHN LINFANTE
Regulation Number880.5200
Classification Product Code
NGT  
Date Received09/26/2008
Decision Date 12/18/2008
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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