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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 K122762
FOIA Releasable 510(k) K122762
Device Name ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR
Applicant
Microsulis Medical Limited
Unit 1 And 2 Falson Ct.
Parklands Business Park
Denmead,  GB PO7 7XP
Applicant Contact STUART MCINTYRE
Correspondent
Microsulis Medical Limited
Unit 1 And 2 Falson Ct.
Parklands Business Park
Denmead,  GB PO7 7XP
Correspondent Contact STUART MCINTYRE
Regulation Number878.4400
Classification Product Code
NEY  
Date Received09/10/2012
Decision Date 11/30/2012
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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