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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name container, empty, for collection & processing of blood & blood components
510(k) Number K760952
Device Name TERASAKI LYMPHOCYTE TRANSPORT KIT
Applicant
DRAVON MEDICAL, INC.
Correspondent
DRAVON MEDICAL, INC.
Regulation Number864.9100
Classification Product Code
KSR  
Date Received11/02/1976
Decision Date 01/17/1977
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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