CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)— 510(k) K970661

Name: FDA 510(k) clearance K970661
Creator: U.S. Food and Drug Administration
Published: 1997-11-12

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K970661 for CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90), Substantially Equivalent on 1997-11-12. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code MSE
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1997-02-21
Decision date: 1997-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

Download summary PDF View on FDA.gov ↗

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K970654 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)1997-11-12

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