The following data is part of a premarket notification filed by Lap Gmbh Laser Applikationen with the FDA for Doradonova Mr3t.
Device ID | K173926 |
510k Number | K173926 |
Device Name: | DORADOnova MR3T |
Classification | Accelerator, Linear, Medical |
Applicant | LAP GmbH Laser Applikationen Zeppelinstrasse 23 Lueneburg, DE 21337 |
Contact | Martin Pfabel |
Correspondent | Martin Pfabel LAP GmbH Laser Applikationen Zeppelinstrasse 23 Lueneburg, DE 21337 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-26 |
Decision Date | 2018-09-14 |
Summary: | summary |