Uramix CuraWay Biopsy Needle

Instrument, Biopsy

Uramix, Inc.

The following data is part of a premarket notification filed by Uramix, Inc. with the FDA for Uramix Curaway Biopsy Needle.

Pre-market Notification Details

Device IDK203141
510k NumberK203141
Device Name:Uramix CuraWay Biopsy Needle
ClassificationInstrument, Biopsy
Applicant Uramix, Inc. 272 N. Lansdowne Ave. Lansdowne,  PA  19050
ContactMichael Mooreville
CorrespondentMichael Mooreville
Uramix, Inc 272 N. Lansdowne Ave. Lansdowne,  PA  19050
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-20
Decision Date2021-09-17

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