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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 K141311
Device Name 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE
Applicant
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Applicant Contact JUMA HOSHINO
Correspondent
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Correspondent Contact JUMA HOSHINO
Regulation Number880.5200
Classification Product Code
NGT  
Date Received05/20/2014
Decision Date 07/25/2014
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
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