The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Finesse Ultra Breast Biopsy System Driver (blue, Pink).
| Device ID | K103359 |
| 510k Number | K103359 |
| Device Name: | FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) |
| Classification | Instrument, Biopsy |
| Applicant | C.R. BARD, INC. 1415 W 3RD STREET Tempe, AZ 85281 |
| Contact | Cindy Moss |
| Correspondent | Cindy Moss C.R. BARD, INC. 1415 W 3RD STREET Tempe, AZ 85281 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-16 |
| Decision Date | 2010-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741085147 | K103359 | 000 |