The following data is part of a premarket notification filed by Implant Sciences Corp. with the FDA for I-plant, Model 3500.
| Device ID | K994317 |
| 510k Number | K994317 |
| Device Name: | I-PLANT, MODEL 3500 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | IMPLANT SCIENCES CORP. 107 AUDUBON ROAD, #5 Wakefield, MA 01880 -1246 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L Schrayer IMPLANT SCIENCES CORP. 107 AUDUBON ROAD, #5 Wakefield, MA 01880 -1246 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-22 |
| Decision Date | 2000-03-21 |
| Summary: | summary |