The following data is part of a premarket notification filed by Radiomed Corporation with the FDA for Pre-loaded Gold Visicoil Ck Marker.
| Device ID | K120859 |
| 510k Number | K120859 |
| Device Name: | PRE-LOADED GOLD VISICOIL CK MARKER |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | RADIOMED CORPORATION 3150 STAGE POST DRIVE Bartlett, TN 38133 |
| Contact | Gordon Roberts |
| Correspondent | Gordon Roberts RADIOMED CORPORATION 3150 STAGE POST DRIVE Bartlett, TN 38133 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-22 |
| Decision Date | 2012-04-19 |
| Summary: | summary |