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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K160180
Device Name Intermittent Pneumatic Compression system
Applicant
Daesung Maref Co., Ltd.
298-24, Gongdan-Ro
Gunpo-Si,  KR 15809
Applicant Contact Jae-wha Lee
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number870.5800
Classification Product Code
JOW  
Date Received01/27/2016
Decision Date 11/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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