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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 K831004
Device Name AUTOMATED 8400 BLOOD CELL SEPARATOR
Applicant
INTL. BUSINESS MACHINES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
INTL. BUSINESS MACHINES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Classification Product Code
LKN  
Date Received03/29/1983
Decision Date 09/12/1983
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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