Thales 3D Mr Scanner

Accelerator, Linear, Medical

LAP GmbH Laser Applikationen

The following data is part of a premarket notification filed by Lap Gmbh Laser Applikationen with the FDA for Thales 3d Mr Scanner.

Pre-market Notification Details

Device IDK200907
510k NumberK200907
Device Name:Thales 3D Mr Scanner
ClassificationAccelerator, Linear, Medical
Applicant LAP GmbH Laser Applikationen Zeppelinstrasse 23 Lueneburg,  DE 21335
ContactMartin Pfabel
CorrespondentMartin Pfabel
LAP GmbH Laser Applikationen Zeppelinstrasse 23 Lueneburg,  DE 21335
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-06
Decision Date2020-06-03

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