Disposable Automatic Core Biopsy Instrument

Instrument, Biopsy

Suzhou Leapmed Healthcare Corporation

The following data is part of a premarket notification filed by Suzhou Leapmed Healthcare Corporation with the FDA for Disposable Automatic Core Biopsy Instrument.

Pre-market Notification Details

Device IDK212284
510k NumberK212284
Device Name:Disposable Automatic Core Biopsy Instrument
ClassificationInstrument, Biopsy
Applicant Suzhou Leapmed Healthcare Corporation Wuzhong Science Park, NO.2 & NO.3 Building 38# North Guandu Road, Wuzhong District Suzhou,  CN 215100
ContactYu Zhu
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai,  CN 200120
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-21
Decision Date2021-11-10

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