The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17ggp.
| Device ID | K080698 |
| 510k Number | K080698 |
| Device Name: | GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP |
| Classification | Marker, Radiographic, Implantable |
| Applicant | SENORX, INC. 11 COLUMBIA Aliso Viejo, CA 92656 |
| Contact | Eben Gordon |
| Correspondent | Eben Gordon SENORX, INC. 11 COLUMBIA Aliso Viejo, CA 92656 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-12 |
| Decision Date | 2008-03-31 |
| Summary: | summary |