GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER— 510(k) K994390

Substantially Equivalent

Gambro Healthcare

FDA 510(k) clearance K994390 for GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER, Substantially Equivalent on 2000-10-26. Applicant: Gambro Healthcare.

Clearance details

Applicant: Gambro Healthcare
Product code: Code MSF
Advisory panel: Gastroenterology, Urology
Date received: 1999-12-28
Decision date: 2000-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

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