Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles

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 Automatic Biopsy Needles, Promisemed Co-axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles.

Pre-market Notification Details

Device IDK210946
510k NumberK210946
Device Name:Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
ClassificationInstrument, Biopsy
Applicant Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street, Cangqian Community, Yuhang District Hangzhou City,  CN 311121
ContactZearou Yang
CorrespondentWei Shan Hsu
Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong,  CN
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-30
Decision Date2021-08-12

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