The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Encor Breast Biopsy System.
| Device ID | K093512 |
| 510k Number | K093512 |
| Device Name: | ENCOR BREAST BIOPSY SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | SENORX, INC. 3 MORGAN Irvine, CA 92618 |
| Contact | Eben Gordon |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-11-13 |
| Decision Date | 2009-11-20 |
| Summary: | summary |