The following data is part of a premarket notification filed by Mds Nordion with the FDA for Raycell.
Device ID | K032684 |
510k Number | K032684 |
Device Name: | RAYCELL |
Classification | Irradiator, Blood To Prevent Graft Versus Host Disease |
Applicant | MDS NORDION 447 MARCH RD. Ottawa, Ontario, CA K2k1x8 |
Contact | A. Warbick-cerone |
Correspondent | A. Warbick-cerone MDS NORDION 447 MARCH RD. Ottawa, Ontario, CA K2k1x8 |
Product Code | MOT |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-29 |
Decision Date | 2003-09-26 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RAYCELL 87555854 5471426 Live/Registered |
Hebei Yafei Leather Manufacturing Co,Ltd. 2017-08-04 |
RAYCELL 76581218 3500500 Live/Registered |
BEST THERATRONICS LTD. 2004-03-16 |
RAYCELL 74026137 not registered Dead/Abandoned |
Guilford Mills, Inc. 1990-02-06 |