RAYCELL

Irradiator, Blood To Prevent Graft Versus Host Disease

MDS NORDION

The following data is part of a premarket notification filed by Mds Nordion with the FDA for Raycell.

Pre-market Notification Details

• Device ID: K032684
• 510k Number: K032684
• Device Name: RAYCELL
• Classification: Irradiator, Blood To Prevent Graft Versus Host Disease
• Applicant: MDS NORDION 447 MARCH RD. Ottawa, Ontario, CA K2k1x8
• Contact: A. Warbick-cerone
• Correspondent: A. Warbick-cerone; 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: 2003-08-29
• Decision Date: 2003-09-26
• Summary: summary