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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 K142620
Device Name 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe
Applicant
Excelsior Medical Corporation
1933 Heck Ave.
Neptune,  NJ  07553
Applicant Contact John Linfante
Correspondent
Excelsior Medical Corporation
1933 Heck Ave.
Neptune,  NJ  07553
Correspondent Contact John Linfante
Regulation Number880.5200
Classification Product Code
NGT  
Date Received09/16/2014
Decision Date 12/12/2014
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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