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 |