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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 K042061
Device Name 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
Applicant
Becton Dickinson
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact PETER ZURLO
Correspondent
Becton Dickinson
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact PETER ZURLO
Regulation Number880.5200
Classification Product Code
NGT  
Date Received08/02/2004
Decision Date 08/26/2004
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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