The following data is part of a premarket notification filed by Vivant Medical, Inc. with the FDA for Encircle Localization Device.
| Device ID | K022286 |
| 510k Number | K022286 |
| Device Name: | ENCIRCLE LOCALIZATION DEVICE |
| Classification | Instrument, Biopsy |
| Applicant | VIVANT MEDICAL, INC. 1916-A OLD MIDDLEFIELD WAY Mountain View, CA 94043 |
| Contact | Steven Kim |
| Correspondent | Steven Kim VIVANT MEDICAL, INC. 1916-A OLD MIDDLEFIELD WAY Mountain View, CA 94043 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-15 |
| Decision Date | 2002-10-11 |
| Summary: | summary |