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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K851319
Device Name DIALYSIS CONCENTRATE
Applicant
Ries Biologicals
17762 Mitchell St.
P.O. Box 19157
Irvine,  CA  92714
Applicant Contact GIL W MCGUFF
Correspondent
Ries Biologicals
17762 Mitchell St.
P.O. Box 19157
Irvine,  CA  92714
Correspondent Contact GIL W MCGUFF
Date Received04/02/1985
Decision Date 07/02/1985
Decision Substantially Equivalent (SESE)
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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