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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, peritoneal, automatic delivery
510(k) Number K844108
Device Name RENAL SYSTEMS PERITONEAL ACCESS SYSTEM
Applicant
RENAL SYSTEMS, INC.
14905 28TH AVE. N.
MINNEAPOLIS,  MN  55441
Applicant Contact LEROY J FISCHBACH
Correspondent
RENAL SYSTEMS, INC.
14905 28TH AVE. N.
MINNEAPOLIS,  MN  55441
Correspondent Contact LEROY J FISCHBACH
Regulation Number876.5630
Classification Product Code
FKX  
Date Received10/23/1984
Decision Date 01/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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