The following data is part of a premarket notification filed by Math Resolutions, Llc. with the FDA for Millcomp.
| Device ID | K011845 |
| 510k Number | K011845 |
| Device Name: | MILLCOMP |
| Classification | Accelerator, Linear, Medical |
| 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 | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-12 |
| Decision Date | 2001-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B229MC11 | K011845 | 000 |