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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 K830831
Device Name AUTOMATED BLOOD CELL SEPARATOR
Applicant
Cryosan, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cryosan, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
LKN  
Date Received03/16/1983
Decision Date 06/16/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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