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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 K850127
Device Name FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G
Applicant
Computer Dialysis Systems, Inc.
Boulder,  CO  80301
Applicant Contact HOWARD A JANNECK
Correspondent
Computer Dialysis Systems, Inc.
Boulder,  CO  80301
Correspondent Contact HOWARD A JANNECK
Regulation Number876.5820
Classification Product Code
LIF  
Date Received01/14/1985
Decision Date 03/20/1985
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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