BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE— 510(k) K930181

Substantially Equivalent

Fresenius USA, Inc.

FDA 510(k) clearance K930181 for BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE, Substantially Equivalent on 1995-11-29. Applicant: Fresenius USA, Inc..

Clearance details

Applicant: Fresenius USA, Inc.
Product code: Code FKP
Advisory panel: Gastroenterology, Urology
Date received: 1993-01-14
Decision date: 1995-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

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