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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 K193020
Device Name VenaPro Vascular Therapy System
Applicant
Innovamed Health, LLC
270 W 500 N
North Salt Lake,  UT  84054
Applicant Contact Luke Zeutzius
Correspondent
Jkh USA, LLC
20505 Valley Blvd. Suite 108
Walnut,  CA  91789
Correspondent Contact Bill Quanqin Dai
Regulation Number870.5800
Classification Product Code
JOW  
Date Received10/30/2019
Decision Date 12/04/2019
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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