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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, hypodermic, single lumen
510(k) Number K951254
Device Name SAFETYGLIDE NEEDLE
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
ONE BECTON DR.
franklin lakes,  NJ  07417 -1880
Applicant Contact karen l rosencrans
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
ONE BECTON DR.
franklin lakes,  NJ  07417 -1880
Correspondent Contact karen l rosencrans
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/21/1995
Decision Date 10/07/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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