The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Cet Prostate Applicator Set, Part Number 089.066.
| Device ID | K990990 |
| 510k Number | K990990 |
| Device Name: | CET PROSTATE APPLICATOR SET, PART NUMBER 089.066 |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Contact | Ralph E Shuping |
| Correspondent | Ralph E Shuping NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-24 |
| Decision Date | 1999-10-07 |
| Summary: | summary |