Venous Assist System

Sleeve, Limb, Compressible

DAESUNG MAREF CO., LTD.

The following data is part of a premarket notification filed by Daesung Maref Co., Ltd. with the FDA for Venous Assist System.

Pre-market Notification Details

Device IDK150980
510k NumberK150980
Device Name:Venous Assist System
ClassificationSleeve, Limb, Compressible
Applicant DAESUNG MAREF CO., LTD. 298-24, GONGDAN-RO Gunpo-shi,  KR 435-862
ContactJae-wha Lee
CorrespondentDave Kim
Mtech Group 8310 Buffalo Speedway Houston,  TX  77025
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-14
Decision Date2016-05-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
28809315677695 K150980 000
28809315677732 K150980 000
28809315677756 K150980 000
28809315677718 K150980 000
08809315677684 K150980 000

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