The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Biopsy Site Marker.
| Device ID | K011402 |
| 510k Number | K011402 |
| Device Name: | BIOPSY SITE MARKER |
| Classification | Clip, 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 | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-07 |
| Decision Date | 2001-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801741032209 | K011402 | 000 |
| 10801741031882 | K011402 | 000 |
| 10801741031868 | K011402 | 000 |
| 10801741031851 | K011402 | 000 |
| 10801741031844 | K011402 | 000 |