The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Flexisys.
Device ID | K904149 |
510k Number | K904149 |
Device Name: | FLEXISYS |
Classification | Powered Laser Surgical Instrument |
Applicant | DORNIER MEDTECH AMERICA, INC. 824 LIVINGSTON COURT Marietta, GA 30067 |
Contact | Robert E Yocher |
Correspondent | Robert E Yocher DORNIER MEDTECH AMERICA, INC. 824 LIVINGSTON COURT Marietta, GA 30067 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-07 |
Decision Date | 1990-12-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FLEXISYS 78496411 3203415 Dead/Cancelled |
Dornier MedTech GmbH 2004-10-07 |
FLEXISYS 74065780 1888346 Dead/Cancelled |
Messerschmitt-Bolkow-Blohm GmbH 1990-06-04 |