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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 K193611
Device Name Viveve 2.0 System
Applicant
Viveve Medical, Inc.
345 Inverness Drive South, Building B, Suite 250
englewood,  CO  80112
Applicant Contact kevin robison
Correspondent
Viveve Medical, Inc.
345 Inverness Drive South, Building B, Suite 250
englewood,  CO  80112
Correspondent Contact kevin robison
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/26/2019
Decision Date 01/16/2020
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
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