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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 K854259
Device Name SEPACELL R-500 & SEPACELL R-500A
Applicant
Advocacy International, Ltd.
Internationa Sq.
1825 Eye St. NW Suite 400
Washington,  DC  20006
Applicant Contact RICHARD T NEY
Correspondent
Advocacy International, Ltd.
Internationa Sq.
1825 Eye St. NW Suite 400
Washington,  DC  20006
Correspondent Contact RICHARD T NEY
Regulation Number880.5440
Classification Product Code
CAK  
Date Received10/23/1985
Decision Date 01/08/1986
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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