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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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