The following data is part of a premarket notification filed by Ml Strategies, Inc. with the FDA for North American Scientific (nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-a.
| Device ID | K972271 |
| 510k Number | K972271 |
| Device Name: | NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ML STRATEGIES, INC. ONE FINANCIAL CENTER BOSTON, MA 02111 |
| Contact | ALLAN M GREEN |
| Correspondent | ALLAN M GREEN ML STRATEGIES, 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 | 1997-06-18 |
| Decision Date | 1997-10-28 |