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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer Reprocessing System
510(k) Number K850799
Device Name RINSE MACHINE KR-4 KIDNEY RINSE-4
Applicant
Medical Technologies International, Inc.
3922 N. Sagihaw St.
Flint Mi,  MI  48505
Correspondent
Medical Technologies International, Inc.
3922 N. Sagihaw St.
Flint Mi,  MI  48505
Regulation Number876.5820
Classification Product Code
LIF  
Date Received02/27/1985
Decision Date 07/29/1985
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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