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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K840859
Device Name MAKS CENTRAL DELIVERY SYS-11-200 ETC
Applicant
Erika, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Erika, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5820
Classification Product Code
KOC  
Date Received02/24/1984
Decision Date 05/22/1984
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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