The following data is part of a premarket notification filed by Rad Source Technologies, Inc. with the FDA for Rad Source X-ray Blood Irradiator, Model Rs-3400.
Device ID | K082921 |
510k Number | K082921 |
Device Name: | RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 |
Classification | Irradiator, Blood To Prevent Graft Versus Host Disease |
Applicant | RAD SOURCE TECHNOLOGIES, INC. 6825 SHILOH ROAD EAST SUITE B2 Alpharetta, GA 30005 |
Contact | Randol E Kirk |
Correspondent | Randol E Kirk RAD SOURCE TECHNOLOGIES, INC. 6825 SHILOH ROAD EAST SUITE B2 Alpharetta, GA 30005 |
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 | 2008-10-01 |
Decision Date | 2009-02-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860000737005 | K082921 | 000 |