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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Dish, Tissue Culture
510(k) Number K890542
Device Name MULTIWELL CULTURE PLATE INSERTS
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact J ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact J ARNSBERGER
Regulation Number864.2240
Classification Product Code
KIZ  
Date Received02/03/1989
Decision Date 02/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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