FDA.report

510(k) K993944

Device
RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE
Applicant
RITA MEDICAL SYSTEMS
510(k) number
K993944
Product code
GEI  
Decision
Substantially Equivalent (SESE)
Decision date
1999-12-02
Date received
1999-11-19
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ERIN DIGNAN-MAZZONE
Address
967 N. Shoreline Blvd. Mountain View CA US 94043 94043

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
H7877001026230RITAANGIODYNAMICS, INC.2016-09-21

Legacy Summary

summary

FDA Review

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