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 |