SeeFactorCT3

X-ray, Tomography, Computed, Dental

Epica International Inc.

The following data is part of a premarket notification filed by Epica International Inc. with the FDA for Seefactorct3.

Pre-market Notification Details

Device IDK190856
510k NumberK190856
Device Name:SeeFactorCT3
ClassificationX-ray, Tomography, Computed, Dental
Applicant Epica International Inc. 2753 Camino Capistrano. Suite A-101 San Clemente,  CA  92672
ContactDaniel Naimey
CorrespondentFrank Pokrop
Frank Pokrop 3577 Sand Court Carlsbad,  CA  92010
Product CodeOAS  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-02
Decision Date2019-09-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
86000594161101 K190856 000
00860005941605 K190856 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.