The following data is part of a premarket notification filed by Nucletron-oldelft Corp. with the FDA for Microselectron-hdr Version 2.
| Device ID | K953946 |
| 510k Number | K953946 |
| Device Name: | MICROSELECTRON-HDR VERSION 2 |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON-OLDELFT CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2119 |
| Contact | Stephen P Teague |
| Correspondent | Stephen P Teague NUCLETRON-OLDELFT CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2119 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-21 |
| Decision Date | 1996-08-13 |
| Summary: | summary |