Promisemed Fine Biopsy Needle

Instrument, Biopsy

Promisemed Hangzhou Meditech Co., Ltd.

The following data is part of a premarket notification filed by Promisemed Hangzhou Meditech Co., Ltd. with the FDA for Promisemed Fine Biopsy Needle.

Pre-market Notification Details

Device IDK213683
510k NumberK213683
Device Name:Promisemed Fine Biopsy Needle
ClassificationInstrument, Biopsy
Applicant Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street, Cangqian Community,Yuhang District Hangzhou City,  CN 311121
ContactZearou Yang
CorrespondentZearou Yang
Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street, Cangqian Community,Yuhang District Hangzhou City,  CN 311121
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-22
Decision Date2022-04-22

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.