EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS— 510(k) K802880

Name: FDA 510(k) clearance K802880
Creator: U.S. Food and Drug Administration
Published: 1980-12-17

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K802880 for EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS, Substantially Equivalent on 1980-12-17. Applicant: Extracorporeal Medical Specialities, Inc.. Device class: 2.

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code FKP
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1980-11-17
Decision date: 1980-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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