The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Crc 15ultra.
| Device ID | K052595 |
| 510k Number | K052595 |
| Device Name: | CRC 15ULTRA |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
| Contact | Mary Anne Dell |
| Correspondent | Mary Anne Dell CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-21 |
| Decision Date | 2005-11-08 |
| Summary: | summary |