The following data is part of a premarket notification filed by North American Scientific, Inc. with the FDA for Surtrak Implantation Kit.
| Device ID | K060679 |
| 510k Number | K060679 |
| Device Name: | SURTRAK IMPLANTATION KIT |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | NORTH AMERICAN SCIENTIFIC, INC. 20200 SUNBURST ST. Chatsworth, CA 91311 |
| Contact | Leigh Spotten |
| Correspondent | Leigh Spotten NORTH AMERICAN SCIENTIFIC, INC. 20200 SUNBURST ST. Chatsworth, CA 91311 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-15 |
| Decision Date | 2006-04-21 |