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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 K191601
Device Name Valleylab FT10 Electrosurgical Platform
Applicant
Covidien
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact Jennie van Diemen
Correspondent
Covidien
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact Jennie van Diemen
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
OCL  
Date Received06/17/2019
Decision Date 07/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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