The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Valencia Skin Applicator Set, Model: 189.701.
| Device ID | K073107 |
| 510k Number | K073107 |
| Device Name: | VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia, MD 21046 -2133 |
| Contact | Lisa] Dimmick |
| Correspondent | Lisa] Dimmick NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia, MD 21046 -2133 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-02 |
| Decision Date | 2007-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213032095 | K073107 | 000 |
| 08717213032071 | K073107 | 000 |
| 08717213032057 | K073107 | 000 |
| 08717213032033 | K073107 | 000 |