The following data is part of a premarket notification filed by Nucletron-oldelft Corp. with the FDA for Microselectron-hdr (high Dose Rate).
| Device ID | K864210 |
| 510k Number | K864210 |
| Device Name: | MICROSELECTRON-HDR (HIGH DOSE RATE) |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON-OLDELFT CORP. 9160 REDBRANCH RD. Columbia, MD 21045 |
| Contact | Miles Mount |
| Correspondent | Miles Mount NUCLETRON-OLDELFT CORP. 9160 REDBRANCH RD. Columbia, MD 21045 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-28 |
| Decision Date | 1986-11-26 |