OPTILUX 501

Activator, Ultraviolet, For Polymerization

KERR CORPORATION (DANBURY)

The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Optilux 501.

Pre-market Notification Details

Device IDK020091
510k NumberK020091
Device Name:OPTILUX 501
ClassificationActivator, Ultraviolet, For Polymerization
Applicant KERR CORPORATION (DANBURY) 1717 WEST COLLINS AVE. Orange,  CA  92867
ContactColleen Boswell
CorrespondentColleen Boswell
KERR CORPORATION (DANBURY) 1717 WEST COLLINS AVE. Orange,  CA  92867
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-10
Decision Date2002-03-21
Summary:summary

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