PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)— 510(k) K970648

Substantially Equivalent

Renal Systems, Inc.

FDA 510(k) clearance K970648 for PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S), Substantially Equivalent on 1998-01-05. Applicant: Renal Systems, Inc..

Clearance details

Applicant: Renal Systems, Inc.
Product code: Code MSF
Advisory panel: Gastroenterology, Urology
Date received: 1997-02-20
Decision date: 1998-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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