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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name container, empty, for collection & processing of blood & blood components
510(k) Number DK760952
Tradename Terasaki Lymphocyte Transport Kit
Device Name Empty Containers for the Collection & Processing of Blood/Blood Components
Original Applicant
Dravon Medical Inc.
11465 s.e. hwy. 212
clackamas,  OR  97015
Regulation Number864.9100
Classification Product Code
KSR  
Date Received12/20/1976
Decision Date 01/17/1977
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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