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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Separator, Automated, Blood Cell And Plasma, Therapeutic
510(k) Number K895435
Device Name FRESENIUS AS 104 CELL SEPARATOR
Applicant
Fresenius USA, Inc.
4090 Pike Ln.
Concord,  CA  94520
Applicant Contact GARRY J VIBERT
Correspondent
Fresenius USA, Inc.
4090 Pike Ln.
Concord,  CA  94520
Correspondent Contact GARRY J VIBERT
Classification Product Code
LKN  
Date Received09/07/1989
Decision Date 11/02/1990
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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