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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 K162449
Device Name Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
Applicant
ANGIODYNAMICS, INC
26 FOREST STREET
MARLBOROUGH,  MA  01752
Applicant Contact KASEY E NEWCOMB
Correspondent
ANGIODYNAMICS, INC
26 FOREST STREET
MARLBOROUGH,  MA  01752
Correspondent Contact KASEY E NEWCOMB
Regulation Number878.4400
Classification Product Code
NEY  
Date Received09/01/2016
Decision Date 05/05/2017
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
Recalls CDRH Recalls
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