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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 K982541
Device Name VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608
Applicant
BECTON DICKINSON VACUTAINER SYSTEMS
ONE BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Applicant Contact ANDREA HRONCICH
Correspondent
BECTON DICKINSON VACUTAINER SYSTEMS
ONE BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Correspondent Contact ANDREA HRONCICH
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/21/1998
Decision Date 10/28/1998
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
Recalls CDRH Recalls
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