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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
510(k) Number K191073
Device Name Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
Applicant
Vein 360, LLC
4460 Lake Forest Dr.
Blue Ash,  OH  45242
Applicant Contact Suzanne Meyer
Correspondent
Vein 360, LLC
4460 Lake Forest Dr.
Blue Ash,  OH  45242
Correspondent Contact Suzanne Meyer
Regulation Number878.4400
Classification Product Code
NUJ  
Subsequent Product Code
GEI  
Date Received04/22/2019
Decision Date 10/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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