The following data is part of a premarket notification filed by Merit Medical Systems, Inc with the FDA for Temno Elite Biopsy System.
| Device ID | K201166 |
| 510k Number | K201166 |
| Device Name: | Temno Elite Biopsy System |
| Classification | Instrument, Biopsy |
| Applicant | Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Niloufar Samimi |
| Correspondent | Niloufar Samimi Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-01 |
| Decision Date | 2020-08-28 |