The following data is part of a premarket notification filed by Teesuvac Aps with the FDA for Teesuvac Breast Biopsy Device Mark 1.
| Device ID | K212079 |
| 510k Number | K212079 |
| Device Name: | TeesuVac Breast Biopsy Device Mark 1 |
| Classification | Instrument, Biopsy |
| Applicant | TeesuVac ApS Agern Alle 3 Hoersholm, DK Dk-2970 |
| Contact | John Hvidkjaer |
| Correspondent | John Hvidkjaer TeesuVac ApS Agern Alle 3 Hoersholm, DK Dk-2970 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-02 |
| Decision Date | 2022-02-02 |