The following data is part of a premarket notification filed by Nordion International, Inc. with the FDA for Gammacell 3000 Elan.
| Device ID | K952291 |
| 510k Number | K952291 |
| Device Name: | GAMMACELL 3000 ELAN |
| Classification | Irradiator, Blood To Prevent Graft Versus Host Disease |
| Applicant | NORDION INTERNATIONAL, INC. 1800 M STREET, N.W. Washington, DC 20036 |
| Contact | Kathryn L Gleason |
| Correspondent | Kathryn L Gleason NORDION INTERNATIONAL, INC. 1800 M STREET, N.W. Washington, DC 20036 |
| 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 | 1995-05-16 |
| Decision Date | 1995-08-25 |