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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 K874607
Device Name FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
Applicant
Organon Teknika Corp.
800 Capitola Dr.
Durham,  NC  27713
Applicant Contact SHELDON MAZURSKY
Correspondent
Organon Teknika Corp.
800 Capitola Dr.
Durham,  NC  27713
Correspondent Contact SHELDON MAZURSKY
Classification Product Code
LKN  
Date Received11/09/1987
Decision Date 01/27/1988
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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