Intermittent Pneumatic Compression 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 Intermittent Pneumatic Compression System.

Pre-market Notification Details

Device IDK160180
510k NumberK160180
Device Name:Intermittent Pneumatic Compression System
ClassificationSleeve, Limb, Compressible
Applicant DaeSung Maref Co., Ltd 298-24, Gongdan-ro Gunpo-si,  KR 15809
ContactJae-wha Lee
CorrespondentDave Kim
Mtech Group 8310 Buffalo Speedway Houston,  TX  77025
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-27
Decision Date2016-11-03
Summary:summary

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