The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Encor Enspire Breast Biopsy System.
| Device ID | K111100 |
| 510k Number | K111100 |
| Device Name: | ENCOR ENSPIRE BREAST BIOPSY SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | C.R. BARD, INC. 1415 WEST 3RD ST. Tempe, AZ 85281 -1740 |
| Contact | Justin Lovelace |
| Correspondent | Justin Lovelace C.R. BARD, INC. 1415 WEST 3RD ST. Tempe, AZ 85281 -1740 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-20 |
| Decision Date | 2011-06-16 |
| Summary: | summary |