The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Gel Mark Biopsy Site Marker, Models Mkooo1, Mk0004, Mk0007.
| Device ID | K000060 |
| 510k Number | K000060 |
| Device Name: | GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007 |
| Classification | Staple, Implantable |
| Applicant | SENORX, INC. 13766 ALTON PKWY. SUITE 144 Irvine, CA 92677 |
| Contact | Amy Boucly |
| Correspondent | Amy Boucly SENORX, INC. 13766 ALTON PKWY. SUITE 144 Irvine, CA 92677 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-10 |
| Decision Date | 2000-03-27 |