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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 K181217
Device Name VesoFlow Lite DVT Compression Device
Applicant
Caremed Supply, Inc.
7F., No. 2, Lane 235, Baoqiao Rd., Xindien Dist.
New Taipei City,  TW 23145
Applicant Contact Tsung-Hsuan Liu
Correspondent
Caremed Supply, Inc.
7F., No. 2, Lane 235, Baoqiao Rd., Xindien Dist.
New Taipei City,  TW 23145
Correspondent Contact Tsung-Hsuan Liu
Regulation Number870.5800
Classification Product Code
JOW  
Date Received05/07/2018
Decision Date 08/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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