The following data is part of a premarket notification filed by Mazor Robotics Ltd with the FDA for Renaissance System.
Device ID | K110911 |
510k Number | K110911 |
Device Name: | RENAISSANCE SYSTEM |
Classification | Neurological Stereotaxic Instrument |
Applicant | MAZOR ROBOTICS LTD 20 HATA'AS ST. Kfar Saba, IL 44425 |
Contact | Ahava Stein |
Correspondent | Ahava Stein MAZOR ROBOTICS LTD 20 HATA'AS ST. Kfar Saba, IL 44425 |
Product Code | HAW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-31 |
Decision Date | 2011-04-28 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RENAISSANCE SYSTEM 74547552 not registered Dead/Abandoned |
DE BRUIJN WILFORD, KAREN 1994-07-11 |