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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 K965202
Device Name VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lake,  NJ  07417
Applicant Contact EILEEN SCHWEIGHARDT
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lake,  NJ  07417
Correspondent Contact EILEEN SCHWEIGHARDT
Regulation Number862.1675
Classification Product Code
JKA  
Date Received12/26/1996
Decision Date 02/10/1997
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
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