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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 K180584
Device Name Viveve RF System, Secure
Applicant
Viveve, Inc.
345 Inverness Dr. S., Bldg. B, Suite 250
Englewood,  CO  80112
Applicant Contact Suzon Lommel
Correspondent
Viveve, Inc.
345 Inverness Dr. S., Bldg. B, Suite 250
Englewood,  CO  80112
Correspondent Contact Suzon Lommel
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/05/2018
Decision Date 04/06/2018
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
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