The following data is part of a premarket notification filed by Mds Nordion with the FDA for Gammacell 1000 Elite And Gammacell 3000 Elan.
Device ID | K050963 |
510k Number | K050963 |
Device Name: | GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN |
Classification | Irradiator, Blood To Prevent Graft Versus Host Disease |
Applicant | MDS NORDION 447 MARCH RD. Ottawa, Ontario, CA K2k1x8 |
Contact | Ross Kachaniwsky |
Correspondent | Ross Kachaniwsky 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 | 2005-04-18 |
Decision Date | 2005-05-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00754014600021 | K050963 | 000 |
00754014600014 | K050963 | 000 |
07540146000029 | K050963 | 000 |
07540146000012 | K050963 | 000 |