The following data is part of a premarket notification filed by Nordion International, Inc. with the FDA for Gammacell 3000 Elan, Version 1.0 And Gammacell 1000 Elite, Version 1.0.
| Device ID | K963497 |
| 510k Number | K963497 |
| Device Name: | GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 |
| Classification | Irradiator, Blood To Prevent Graft Versus Host Disease |
| Applicant | NORDION INTERNATIONAL, INC. 447 MARCH RD. P.O. BOX 13500 Kanata, Ontario, CA K2k1x8 |
| Contact | Grant Malkoske |
| Correspondent | Grant Malkoske NORDION INTERNATIONAL, INC. 447 MARCH RD. P.O. BOX 13500 Kanata, Ontario, CA K2k1x8 |
| Product Code | MOT |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1996-11-08 |
| Summary: | summary |