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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 K072687
Device Name VALLEYLAB MICROWAVE ABLATION GENERATOR
Applicant
Covidien Lp, Formerly Know AS Valleylab, A Divison
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact PHILIP E AKE
Correspondent
Covidien Lp, Formerly Know AS Valleylab, A Divison
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact PHILIP E AKE
Regulation Number878.4400
Classification Product Code
NEY  
Date Received09/24/2007
Decision Date 11/25/2008
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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