The following data is part of a premarket notification filed by Ml Strategies, Inc. with the FDA for North American Scientific(nasi)pd-103 Radionuclide Brachytherapy Source-model Med3633.
| Device ID | K973363 |
| 510k Number | K973363 |
| Device Name: | NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 |
| Classification | Source, Isotope, Sealed, Gold, Titanium, Platinum |
| 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 | IWI |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-08 |
| Decision Date | 1998-07-02 |