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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, transport, kidney
510(k) Number K801899
Device Name KEITHLEY LYMPHOCYTE DEPLETION CART
Applicant
KEITHLEY DEVELOPMENT CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
KEITHLEY DEVELOPMENT CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5880
Classification Product Code
KDK  
Date Received08/08/1980
Decision Date 09/26/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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