The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Senomark Ultra Breast Tissue Marker.
| Device ID | K123911 |
| 510k Number | K123911 |
| Device Name: | SENOMARK ULTRA BREAST TISSUE MARKER |
| Classification | Marker, Radiographic, Implantable |
| Applicant | C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 -1740 |
| Contact | Sarah Mccartney |
| Correspondent | Sarah Mccartney C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 -1740 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-19 |
| Decision Date | 2013-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801741032407 | K123911 | 000 |
| 10801741032094 | K123911 | 000 |
| 10801741032087 | K123911 | 000 |
| 10801741032070 | K123911 | 000 |
| 10801741032063 | K123911 | 000 |
| 10801741032056 | K123911 | 000 |
| 10801741032049 | K123911 | 000 |
| 10801741032032 | K123911 | 000 |
| 10801741032025 | K123911 | 000 |
| 10801741032018 | K123911 | 000 |
| 10801741032100 | K123911 | 000 |
| 10801741032117 | K123911 | 000 |
| 10801741032391 | K123911 | 000 |
| 10801741032384 | K123911 | 000 |
| 10801741032377 | K123911 | 000 |
| 10801741032360 | K123911 | 000 |
| 10801741032353 | K123911 | 000 |
| 10801741032346 | K123911 | 000 |
| 10801741032339 | K123911 | 000 |
| 10801741032131 | K123911 | 000 |
| 10801741032124 | K123911 | 000 |
| 10801741032001 | K123911 | 000 |