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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, Diagnostic
510(k) Number K822521
Device Name AUTOMATED BLOOD CELL SEPARATOR
Applicant
Cryosan, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Cryosan, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.9245
Classification Product Code
GKT  
Date Received08/23/1982
Decision Date 09/30/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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