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 |