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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 K162547
Device Name Viveve System
Applicant
Viveve, Inc.
150 Commercial St.
Sunnyvale,  CA  94086
Applicant Contact Jim Talbot
Correspondent
Viveve, Inc.
150 Commercial St.
Sunnyvale,  CA  94086
Correspondent Contact Jim Talbot
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/12/2016
Decision Date 10/06/2016
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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