Temno Elite Biopsy System

Instrument, Biopsy

Merit Medical Systems, Inc

The following data is part of a premarket notification filed by Merit Medical Systems, Inc with the FDA for Temno Elite Biopsy System.

Pre-market Notification Details

Device IDK201166
510k NumberK201166
Device Name:Temno Elite Biopsy System
ClassificationInstrument, Biopsy
Applicant Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan,  UT  84095
ContactNiloufar Samimi
CorrespondentNiloufar Samimi
Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan,  UT  84095
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-01
Decision Date2020-08-28

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.