The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Starchmark Biopsy Site Marker, Model Stmkec-10gss, Stmkec-10gtr, Stmkmt-11gs.
| Device ID | K081085 |
| 510k Number | K081085 |
| Device Name: | STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-16 |
| Decision Date | 2008-08-01 |
| Summary: | summary |