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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Capillary, Hollow Fiber
510(k) Number K802893
Device Name CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY
Applicant
Cordis Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Cordis Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5820
Classification Product Code
FJI  
Date Received11/17/1980
Decision Date 02/13/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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