The following data is part of a premarket notification filed by Math Resolutions, Llc. with the FDA for Rtdoseplan.
| Device ID | K022961 |
| 510k Number | K022961 |
| Device Name: | RTDOSEPLAN |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | MATH RESOLUTIONS, LLC. 5975 GALES LN. Columbia, MD 21045 |
| Contact | Wendel Dean Renner |
| Correspondent | Wendel Dean Renner MATH RESOLUTIONS, LLC. 5975 GALES LN. Columbia, MD 21045 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-06 |
| Decision Date | 2003-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B229RTDP21 | K022961 | 000 |