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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 K241085
Device Name Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)
Applicant
Covidien, LLC
200 Medtronic Dr.
Lafayette,  CO  80026
Applicant Contact Aliva Mahunta
Correspondent
Covidien, LLC
200 Medtronic Dr.
Lafayette,  CO  80026
Correspondent Contact Aliva Mahunta
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
OCL  
Date Received04/19/2024
Decision Date 07/12/2024
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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