The following data is part of a premarket notification filed by C-rad Positioning Ab with the FDA for Positioner.
Device ID | K063839 |
510k Number | K063839 |
Device Name: | POSITIONER |
Classification | Accelerator, Linear, Medical |
Applicant | C-RAD POSITIONING AB KUNGSANGSVAGEN 29 Uppsala, SE 75323 |
Contact | Bengt Eric Rosth |
Correspondent | Bengt Eric Rosth C-RAD POSITIONING AB KUNGSANGSVAGEN 29 Uppsala, SE 75323 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-26 |
Decision Date | 2007-02-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POSITIONER 85571422 not registered Dead/Abandoned |
Orthopedic Positioning Solutions, LLC 2012-03-16 |
POSITIONER 75093866 not registered Dead/Abandoned |
Omtron, Inc. 1996-04-25 |
POSITIONER 74223137 1812832 Dead/Cancelled |
A-Dec, Inc. 1991-11-19 |