The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Radionuclide Catheters, Rnc-a, Rnc-g, Rnc-u.
| Device ID | K923697 |
| 510k Number | K923697 |
| Device Name: | RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-24 |
| Decision Date | 1993-12-13 |