The following data is part of a premarket notification filed by Vivant Medical, Inc. with the FDA for Vivant Medical Biopsy Marker System.
| Device ID | K000278 |
| 510k Number | K000278 |
| Device Name: | VIVANT MEDICAL BIOPSY MARKER SYSTEM |
| Classification | Clip, Implantable |
| Applicant | VIVANT MEDICAL, INC. 3210-B ALPINE RD. Portola Valley, CA 94028 |
| Contact | Jack W Moorman |
| Correspondent | Jack W Moorman VIVANT MEDICAL, INC. 3210-B ALPINE RD. Portola Valley, CA 94028 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-31 |
| Decision Date | 2000-06-23 |