The following data is part of a premarket notification filed by Vivant Medical, Inc. with the FDA for Vivant Breast Lesion Localization Device.
| Device ID | K003439 |
| 510k Number | K003439 |
| Device Name: | VIVANT BREAST LESION LOCALIZATION DEVICE |
| Classification | Instrument, Biopsy |
| Applicant | VIVANT MEDICAL, INC. 3210-B ALPINE RD. Portola Valley, CA 94028 |
| Contact | George Hermann |
| Correspondent | George Hermann VIVANT MEDICAL, INC. 3210-B ALPINE RD. Portola Valley, CA 94028 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-06 |
| Decision Date | 2000-12-15 |