The following data is part of a premarket notification filed by Cp Medical with the FDA for Synthetic Absorbable Seeding Spacers Made Of Polydioxanone Material.
| Device ID | K021311 |
| 510k Number | K021311 |
| Device Name: | SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | CP MEDICAL 836 N.E. 24TH AVE. Portland, OR 97232 |
| Contact | Mary Ann Greenawalt |
| Correspondent | Mary Ann Greenawalt 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 | 2002-04-25 |
| Decision Date | 2002-07-13 |
| Summary: | summary |