The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Implant Guidance System Applicator Set.
| Device ID | K020015 |
| 510k Number | K020015 |
| Device Name: | IMPLANT GUIDANCE SYSTEM APPLICATOR SET |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Contact | Lisa Dimmick |
| Correspondent | Lisa Dimmick 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 | 2002-01-03 |
| Decision Date | 2002-03-13 |
| Summary: | summary |