MODEL DM 353 & DM-353-L SINGLE NEEDLE— 510(k) K792174

Name: FDA 510(k) clearance K792174
Creator: U.S. Food and Drug Administration
Published: 1979-11-16

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K792174 for MODEL DM 353 & DM-353-L SINGLE NEEDLE, Substantially Equivalent on 1979-11-16. Applicant: Extracorporeal Medical Specialities, Inc.. Device class: 2.

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code FIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1979-10-29
Decision date: 1979-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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