The following data is part of a premarket notification filed by Cp Medical with the FDA for Modification To Accu-space Plain Gut Absorbable Seeding Spacers.
| Device ID | K013964 |
| 510k Number | K013964 |
| Device Name: | MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | CP MEDICAL P.O. BOX 6724 Portland, OR 97208 |
| Contact | Mary Ann Greenwalt |
| Correspondent | Mary Ann Greenwalt CP MEDICAL P.O. BOX 6724 Portland, OR 97208 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-03 |
| Decision Date | 2002-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813787021669 | K013964 | 000 |
| 00813787021652 | K013964 | 000 |