THE VENOUS ASSIST SYSTEM— 510(k) K112677

Name: FDA 510(k) clearance K112677
Creator: U.S. Food and Drug Administration
Published: 2012-01-13

Substantially Equivalent

Daesung Maref Co., Ltd.

FDA 510(k) clearance K112677 for THE VENOUS ASSIST SYSTEM, Substantially Equivalent on 2012-01-13. Applicant: Daesung Maref Co., Ltd.. Device class: 2.

Clearance details

Applicant: Daesung Maref Co., Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2011-09-14
Decision date: 2012-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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