THE 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 The Venous Assist System.

Pre-market Notification Details

Device IDK112677
510k NumberK112677
Device Name:THE VENOUS ASSIST SYSTEM
ClassificationSleeve, Limb, Compressible
Applicant DAESUNG MAREF CO., LTD. 4568 WEST 1ST STREET SUITE 104 Los Angeles,  CA  90004
ContactDaniel Nam
CorrespondentDaniel Nam
DAESUNG MAREF CO., LTD. 4568 WEST 1ST STREET SUITE 104 Los Angeles,  CA  90004
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-14
Decision Date2012-01-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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38809315678798 K112677 000
38809315678750 K112677 000
08809315678384 K112677 000

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