The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Senorx Es-300.
| Device ID | K030473 |
| 510k Number | K030473 |
| Device Name: | SENORX ES-300 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SENORX, INC. 11 COLUMBIA, SUITE A Aliso Viejo, CA 92656 |
| Contact | Amy Boucly |
| Correspondent | Donald James Sherratt INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-02-12 |
| Decision Date | 2003-02-26 |
| Summary: | summary |