The following data is part of a premarket notification filed by North American Scientific, Inc. with the FDA for North American Scientific (nasi) 1-125 Radionuclide Brachytherapy Source.
| Device ID | K964647 |
| 510k Number | K964647 |
| Device Name: | NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | NORTH AMERICAN SCIENTIFIC, INC. ONE FINANCIAL CENTER Boston, MA 02111 |
| Contact | Allan M Green |
| Correspondent | Allan M Green NORTH AMERICAN SCIENTIFIC, INC. ONE FINANCIAL CENTER Boston, MA 02111 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-20 |
| Decision Date | 1997-02-10 |