The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue Marker.
| Device ID | K131654 |
| 510k Number | K131654 |
| Device Name: | STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER |
| Classification | Marker, Radiographic, Implantable |
| Applicant | SENORX, INC. 1625 West 3rd Street Tempe, AZ 85281 |
| Contact | Sarah Mccartney |
| Correspondent | Sarah Mccartney SENORX, INC. 1625 West 3rd Street Tempe, AZ 85281 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-06 |
| Decision Date | 2013-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801741032193 | K131654 | 000 |
| 10801741032186 | K131654 | 000 |
| 10801741032179 | K131654 | 000 |
| 10801741032162 | K131654 | 000 |