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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name microfilter, blood transfusion
510(K) Number K896664
Device Name MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT
Applicant
ASAHI MEDICAL CO., LTD.
intl. square
1825 eye st., n.w., suite 400
washington,  DC  20006
Contact anderson
Regulation Number880.5440
Classification Product Code
CAK  
Date Received11/24/1989
Decision Date 01/24/1990
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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