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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 K980098
Device Name VACUTAINER BRAND PRONTO NEEDLES HOLDER
Applicant
Becton Dickinson Vacutainer Systems
One Becton Dr.
Franklin Lakes,  NJ  07417 -1885
Applicant Contact JOHN SCHALAGO
Correspondent
Becton Dickinson Vacutainer Systems
One Becton Dr.
Franklin Lakes,  NJ  07417 -1885
Correspondent Contact JOHN SCHALAGO
Regulation Number862.1675
Classification Product Code
JKA  
Date Received01/12/1998
Decision Date 02/05/1998
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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