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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 K052919
Device Name MICROSULIS TISSUE ABLATION SYSTEM
Applicant
Microsulis Americas, Inc.
275 Wyman St.,Suite 12
Waltham,  MA  02451
Applicant Contact TIMOTHY Y COWART
Correspondent
Microsulis Americas, Inc.
275 Wyman St.,Suite 12
Waltham,  MA  02451
Correspondent Contact TIMOTHY Y COWART
Regulation Number878.4400
Classification Product Code
NEY  
Date Received10/17/2005
Decision Date 01/13/2006
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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