COIL DIALYSIS, MODELS DM-360 AND DM-360-— 510(k) K790382

Name: FDA 510(k) clearance K790382
Creator: U.S. Food and Drug Administration
Published: 1979-05-02

Substantially Equivalent

Estracorporeal, Inc.

FDA 510(k) clearance K790382 for COIL DIALYSIS, MODELS DM-360 AND DM-360-, Substantially Equivalent on 1979-05-02. Applicant: Estracorporeal, Inc.. Device class: 2.

Clearance details

Applicant: Estracorporeal, Inc.
Product code: Code FKD
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1979-02-27
Decision date: 1979-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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