The following data is part of a premarket notification filed by Cp Medical with the FDA for Cp-sleeve.
| Device ID | K013975 |
| 510k Number | K013975 |
| Device Name: | CP-SLEEVE |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | CP MEDICAL 836 N.E. 24TH AVE. Portland, OR 97232 |
| Contact | Mary Ann Greenwalt |
| Correspondent | Mary Ann Greenwalt CP MEDICAL 836 N.E. 24TH AVE. Portland, OR 97232 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-03 |
| Decision Date | 2002-02-22 |
| Summary: | summary |