The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Microselectron Hdr V2, Model 105.999.
| Device ID | K092804 |
| 510k Number | K092804 |
| Device Name: | MICROSELECTRON HDR V2, MODEL 105.999 |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON CORP. 8671 ROBERT FULTON DRIVE Columbia, MD 21046 |
| Contact | Elaina Colby |
| Correspondent | Elaina Colby NUCLETRON CORP. 8671 ROBERT FULTON DRIVE 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 | 2009-09-11 |
| Decision Date | 2009-10-08 |
| Summary: | summary |