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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 K902149
FOIA Releasable 510(k) K902149
Device Name FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM
Applicant
Fresenius/Delmed, Inc.
4090 Pike Ln.
Concord,  CA  94520
Applicant Contact THOMAS E CANE
Correspondent
Fresenius/Delmed, Inc.
4090 Pike Ln.
Concord,  CA  94520
Correspondent Contact THOMAS E CANE
Regulation Number876.5630
Classification Product Code
FKX  
Date Received05/15/1990
Decision Date 10/30/1990
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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