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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 K232640
Device Name Venowave VW5
Applicant
Thermabright
4035 Cinwood St. NW
Massillon,  OH  44646
Applicant Contact Liane Parker
Correspondent
Thermabright
4035 Cinwood St. NW
Massillon,  OH  44646
Correspondent Contact Liane Parker
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/25/2023
Decision Date 06/25/2024
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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