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 |