The following data is part of a premarket notification filed by Milex Products, Inc. with the FDA for Kopans Hookwire Lesion Localization Needle.
| Device ID | K900903 |
| 510k Number | K900903 |
| Device Name: | KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE |
| Classification | Guide, Needle, Surgical |
| Applicant | MILEX PRODUCTS, INC. 5915 NORTHWEST HIGHWAY Chicago, IL 60631 |
| Contact | Robert Shaw |
| Correspondent | Robert Shaw MILEX PRODUCTS, INC. 5915 NORTHWEST HIGHWAY Chicago, IL 60631 |
| Product Code | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-27 |
| Decision Date | 1990-05-03 |