MOD. DM-357 BICARBONATE RETROFIT KIT— 510(k) K800772

Name: FDA 510(k) clearance K800772
Creator: U.S. Food and Drug Administration
Published: 1980-05-14

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K800772 for MOD. DM-357 BICARBONATE RETROFIT KIT, Substantially Equivalent on 1980-05-14. Applicant: Extracorporeal Medical Specialities, Inc.. Device class: 2.

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code FKR
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1980-04-07
Decision date: 1980-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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