The following data is part of a premarket notification filed by Core Medical, Inc. with the FDA for Core Medical Biopsy Needle.
| Device ID | K914732 |
| 510k Number | K914732 |
| Device Name: | CORE MEDICAL BIOPSY NEEDLE |
| Classification | Biopsy Needle |
| Applicant | CORE MEDICAL, INC. 795 DAVIDSON DRIVE NORTH WEST Concord, NC 28025 |
| Contact | Donald F Ryan |
| Correspondent | Donald F Ryan CORE MEDICAL, INC. 795 DAVIDSON DRIVE NORTH WEST Concord, NC 28025 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-21 |
| Decision Date | 1992-01-07 |