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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K141357
Device Name BARRX FLEX RFA ENERGY GENERATOR
Applicant
Covidien Iic
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact Tim Thomas
Correspondent
Covidien Iic
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact Tim Thomas
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/23/2014
Decision Date 08/21/2014
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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