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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K192406
Device Name AveCure BT Microwave Ablation System
Applicant
Medwaves, Inc.
16760 W Bernardo Dr.
San Diego,  CA  92127
Applicant Contact Theodore Ormsby
Correspondent
Medwaves, Inc.
16760 W Bernardo Dr.
San Diego,  CA  92127
Correspondent Contact Theodore Ormsby
Regulation Number878.4400
Classification Product Code
NEY  
Date Received09/04/2019
Decision Date 11/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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