The following data is part of a premarket notification filed by Core Medical, Inc. with the FDA for Breast Lesion Localization Needle.
| Device ID | K924270 |
| 510k Number | K924270 |
| Device Name: | BREAST LESION LOCALIZATION NEEDLE |
| Classification | Guide, Needle, Surgical |
| Applicant | CORE MEDICAL, INC. 795 DAVIDSON DRIVE NORTH WEST Concord, NC 28025 |
| Contact | Don Ryan |
| Correspondent | Don Ryan CORE MEDICAL, INC. 795 DAVIDSON DRIVE NORTH WEST Concord, NC 28025 |
| Product Code | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-24 |
| Decision Date | 1992-09-23 |