The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Gel Mark V.
| Device ID | K050090 |
| 510k Number | K050090 |
| Device Name: | GEL MARK V |
| 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 | 2005-01-14 |
| Decision Date | 2005-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801741032155 | K050090 | 000 |
| 10801741031929 | K050090 | 000 |
| 10801741031936 | K050090 | 000 |
| 10801741031943 | K050090 | 000 |
| 10801741031950 | K050090 | 000 |
| 10801741031967 | K050090 | 000 |
| 10801741031974 | K050090 | 000 |
| 10801741031981 | K050090 | 000 |
| 10801741031998 | K050090 | 000 |
| 10801741032148 | K050090 | 000 |
| 10801741031912 | K050090 | 000 |