Venous Assist System— 510(k) K150980

Substantially Equivalent

Daesung Maref Co., Ltd.

FDA 510(k) clearance K150980 for Venous Assist System, Substantially Equivalent on 2016-05-12. 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: 2015-04-14
Decision date: 2016-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunpo-Shi, KR

Download summary PDF View on FDA.gov ↗

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