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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. Sq.
1825 Eye St., NW Suite 400
Washington,  DC  20006
Applicant Contact ANDERSON
Correspondent
Asahi Medical Co., Ltd.
Intl. Sq.
1825 Eye St., NW Suite 400
Washington,  DC  20006
Correspondent Contact ANDERSON
Regulation Number880.5440
Classification Product Code
CAK  
Date Received11/24/1989
Decision Date 01/24/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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