The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067.
| Device ID | K003270 |
| 510k Number | K003270 |
| Device Name: | PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Contact | Robert Applebaum |
| Correspondent | Robert Applebaum NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-18 |
| Decision Date | 2000-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213052888 | K003270 | 000 |