The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Gel Mark Iv.
| Device ID | K040706 |
| 510k Number | K040706 |
| Device Name: | GEL MARK IV |
| Classification | Marker, Radiographic, Implantable |
| Applicant | SENORX, INC. 11 COLUMBIA, SUITE A Aliso Viejo, CA 92656 |
| Contact | Amy Boucly |
| Correspondent | Amy Boucly SENORX, INC. 11 COLUMBIA, SUITE A 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 | 2004-03-18 |
| Decision Date | 2004-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801741031905 | K040706 | 000 |
| 10801741031899 | K040706 | 000 |