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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 K221883
Device Name Solero Microwave Tissue Ablation (MTA) System and Accessories
Applicant
AngioDynamics, Inc.
26 Forest St.
Marlborough,  MA  01752
Applicant Contact Kasey E Newcomb
Correspondent
AngioDynamics, Inc.
26 Forest St.
Marlborough,  MA  01752
Correspondent Contact Kasey E Newcomb
Regulation Number878.4400
Classification Product Code
NEY  
Date Received06/29/2022
Decision Date 03/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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