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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 K100786
Device Name MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX
Applicant
Bsd Medical Corp.
148 S. 1200 E.
Salt Lake City,  UT  84102
Applicant Contact DIXIE TOOLSON SELLS
Correspondent
Bsd Medical Corp.
148 S. 1200 E.
Salt Lake City,  UT  84102
Correspondent Contact DIXIE TOOLSON SELLS
Regulation Number878.4400
Classification Product Code
NEY  
Date Received03/19/2010
Decision Date 08/13/2010
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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