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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 K203016
Device Name DVT-2600
Applicant
Daesung Maref Co., Ltd.
298-24, Gongdan-Ro
Gunpo-Si,  KR 15809
Applicant Contact Su Hyeon So
Correspondent
Daesung Maref Co., Ltd.
298-24, Gongdan-Ro
Gunpo-Si,  KR 15809
Correspondent Contact Su Hyeon So
Regulation Number870.5800
Classification Product Code
JOW  
Date Received10/01/2020
Decision Date 12/05/2020
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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