The following data is part of a premarket notification filed by N-s Medical Products with the FDA for Hawkins Breast Localization Needle.
| Device ID | K870523 |
| 510k Number | K870523 |
| Device Name: | HAWKINS BREAST LOCALIZATION NEEDLE |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | N-S MEDICAL PRODUCTS 4435 S.W. 35TH TERRACE SUITE 360 Gainesville, FL 32608 |
| Contact | Keith L Stahl |
| Correspondent | Keith L Stahl N-S MEDICAL PRODUCTS 4435 S.W. 35TH TERRACE SUITE 360 Gainesville, FL 32608 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-06 |
| Decision Date | 1987-03-09 |