APrioCore Plus

Instrument, Biopsy

AprioMed AB

The following data is part of a premarket notification filed by Apriomed Ab with the FDA for Apriocore Plus.

Pre-market Notification Details

Device IDK193268
510k NumberK193268
Device Name:APrioCore Plus
ClassificationInstrument, Biopsy
Applicant AprioMed AB Virdings Alle 28 Uppsala,  SE 75450
ContactKatrin Svensson
CorrespondentKatrin Svensson
AprioMed AB Virdings Alle 28 Uppsala,  SE 75450
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGeneral & Plastic Surgery
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-26
Decision Date2020-02-27

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