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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 K160754
Device Name Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
Applicant
Venclose, Inc.
2570 N. 1st., 2nd Floor #221
San Jose,  CA  95131
Applicant Contact MAI LY WILCOX
Correspondent
Pamela M. Buckman, Msn
2800 Pleasant Hill Rd. #175
Pleasant Hill,  CA  94523
Correspondent Contact PAMELA M. BUCKMAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/18/2016
Decision Date 09/09/2016
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
Recalls CDRH Recalls
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