FDA.report

510(k) K162547

Device
Viveve System
Applicant
Viveve Inc.
510(k) number
K162547
Product code
GEI  
Decision
Substantially Equivalent (SESE)
Decision date
2016-10-06
Date received
2016-09-12
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jim Talbot
Address
150 Commercial St. Sunnyvale CA US 94086 94086

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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