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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 K082565
Device Name MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200
Applicant
Microsurgeon, Inc.
20363 E. Tulip Cir.
Montrose,  CO  81403
Applicant Contact DUDLEY HARRIS
Correspondent
Microsurgeon, Inc.
20363 E. Tulip Cir.
Montrose,  CO  81403
Correspondent Contact DUDLEY HARRIS
Regulation Number878.4400
Classification Product Code
NEY  
Date Received09/04/2008
Decision Date 02/12/2009
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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