VISTEO

Unit, X-ray, Extraoral With Timer

OWANDY

The following data is part of a premarket notification filed by Owandy with the FDA for Visteo.

Pre-market Notification Details

Device IDK093105
510k NumberK093105
Device Name:VISTEO
ClassificationUnit, X-ray, Extraoral With Timer
Applicant OWANDY 845 ARONSON LAKE COURT Roswell,  GA  30075
ContactJay Mansour
CorrespondentJay Mansour
OWANDY 845 ARONSON LAKE COURT Roswell,  GA  30075
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-01
Decision Date2010-10-18
Summary:summary

Trademark Results [VISTEO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VISTEO
VISTEO
78775453 not registered Dead/Abandoned
Harmonic, Inc.
2005-12-16

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