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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vacuum Sample, With Anticoagulant
510(k) Number K945458
Device Name VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lake,  NJ  07417
Applicant Contact MELANIE T O'NEILL
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lake,  NJ  07417
Correspondent Contact MELANIE T O'NEILL
Regulation Number862.1675
Classification Product Code
GIM  
Date Received11/07/1994
Decision Date 02/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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