The following data is part of a premarket notification filed by Starmedtec Gmbh with the FDA for Auriga Qi.
Device ID | K121570 |
510k Number | K121570 |
Device Name: | AURIGA QI |
Classification | Powered Laser Surgical Instrument |
Applicant | STARMEDTEC GMBH KREUZSTRASSE 22 Starnberg, DE 82319 |
Contact | Gregor Weidemann |
Correspondent | Gregor Weidemann STARMEDTEC GMBH KREUZSTRASSE 22 Starnberg, DE 82319 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-29 |
Decision Date | 2013-01-16 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AURIGA QI 85485913 4390371 Live/Registered |
BOSTON SCIENTIFIC LIMITED 2011-12-02 |