The following data is part of a premarket notification filed by Promex, Inc. with the FDA for Prostate Seeding Needle.
| Device ID | K973184 |
| 510k Number | K973184 |
| Device Name: | PROSTATE SEEDING NEEDLE |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | PROMEX, INC. 1125 BROOKSIDE AVE. SUITE G500 Indianapolis, IN 46202 |
| Contact | Joseph L Mark |
| Correspondent | Joseph L Mark PROMEX, INC. 1125 BROOKSIDE AVE. SUITE G500 Indianapolis, IN 46202 |
| Product Code | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-25 |
| Decision Date | 1997-11-21 |