The following data is part of a premarket notification filed by Hart Enterprises, Inc. with the FDA for Breast Localization Needles.
| Device ID | K881730 |
| 510k Number | K881730 |
| Device Name: | BREAST LOCALIZATION NEEDLES |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | HART ENTERPRISES, INC. 2131 MARTINDALE SW Wyoming, MI 49509 |
| Contact | Alan Taylor |
| Correspondent | Alan Taylor HART ENTERPRISES, INC. 2131 MARTINDALE SW Wyoming, MI 49509 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-22 |
| Decision Date | 1988-05-13 |