EXP 600 PARALLEL PLATE DIALYZER— 510(k) K811440

Name: FDA 510(k) clearance K811440
Creator: U.S. Food and Drug Administration
Published: 1981-06-12

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K811440 for EXP 600 PARALLEL PLATE DIALYZER, Substantially Equivalent on 1981-06-12. Applicant: Extracorporeal Medical Specialities, Inc.. Device class: 2.

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code FJG
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1981-05-22
Decision date: 1981-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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