BICARB-O-MATE HEMODIALYSIS SOD. BICARB.— 510(k) K802465

Name: FDA 510(k) clearance K802465
Creator: U.S. Food and Drug Administration
Published: 1980-11-12

Substantially Equivalent

Renal Systems, Inc.

FDA 510(k) clearance K802465 for BICARB-O-MATE HEMODIALYSIS SOD. BICARB., Substantially Equivalent on 1980-11-12. Applicant: Renal Systems, Inc.. Device class: 2.

Clearance details

Applicant: Renal Systems, Inc.
Product code: Code FKR
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1980-10-09
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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