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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 K991702
Device Name MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578
Applicant
BECTON DICKINSON VACUTAINER SYSTEMS
ONE BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Applicant Contact ANDREA HRONCICCH
Correspondent
BECTON DICKINSON VACUTAINER SYSTEMS
ONE BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Correspondent Contact ANDREA HRONCICCH
Regulation Number862.1675
Classification Product Code
JKA  
Date Received05/19/1999
Decision Date 07/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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