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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 K905217
Device Name FORMASURE TEST REAGENT
Applicant
Di-Chem, Inc.
10550 County Rd. 81
Maple Grove,  MN  55369
Applicant Contact DWAYNE K BUCHHOLZ
Correspondent
Di-Chem, Inc.
10550 County Rd. 81
Maple Grove,  MN  55369
Correspondent Contact DWAYNE K BUCHHOLZ
Regulation Number876.5820
Classification Product Code
LIF  
Date Received11/20/1990
Decision Date 04/09/1991
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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