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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 K900105
Device Name COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC
Applicant
Cobe Laboratories, Inc.
1185 Oak St.
Lakewood,  CO  80215
Applicant Contact MOORE, JR.
Correspondent
Cobe Laboratories, Inc.
1185 Oak St.
Lakewood,  CO  80215
Correspondent Contact MOORE, JR.
Classification Product Code
LKN  
Date Received01/09/1990
Decision Date 03/22/1991
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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