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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tubes, vials, systems, serum separators, blood collection
510(k) Number K991088
Device Name VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE
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 Number862.1675
Classification Product Code
JKA  
Date Received04/01/1999
Decision Date 05/28/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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