The following data is part of a premarket notification filed by Promex, Inc. with the FDA for Breast Lesion Localization Needle.
| Device ID | K945124 |
| 510k Number | K945124 |
| Device Name: | BREAST LESION LOCALIZATION NEEDLE |
| Classification | Guide, Needle, Surgical |
| 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 | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-19 |
| Decision Date | 1994-11-22 |