Dornier Thulio

Powered Laser Surgical Instrument

DornierMedTech America, Inc

The following data is part of a premarket notification filed by Dorniermedtech America, Inc with the FDA for Dornier Thulio.

Pre-market Notification Details

Device IDK213252
510k NumberK213252
Device Name:Dornier Thulio
ClassificationPowered Laser Surgical Instrument
Applicant DornierMedTech America, Inc 1155 Roberts Blvd, Suite 100 Kennesaw,  GA  30144
ContactJohn Hoffer
CorrespondentJohn Hoffer
DornierMedTech America, Inc 1155 Roberts Blvd, Suite 100 Kennesaw,  GA  30144
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-30
Decision Date2022-07-27

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.