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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 K241096
Device Name Venera 608 Deep Vein Thrombosis (DVT) Prevention System
Applicant
Suzhou Minhua Medical Apparatus Supplies Co., Ltd
You Yi Industrial Park, Songlin Town, Wujiang
Suzhou,  CN 215222
Applicant Contact Alex Wang
Correspondent
Suzhou Minhua Medical Apparatus Supplies Co., Ltd
You Yi Industrial Park, Songlin Town, Wujiang
Suzhou,  CN 215222
Correspondent Contact Alex Wang
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/22/2024
Decision Date 01/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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