Disposable Semi Automatic 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 Semi Automatic Biopsy Instrument.

Pre-market Notification Details

Device IDK212820
510k NumberK212820
Device Name:Disposable Semi Automatic 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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-03
Decision Date2022-07-06

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