Disposable Coaxial Biopsy Needle

Biopsy Needle

Suzhou Leapmed Healthcare Corporation

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

Pre-market Notification Details

Device IDK212822
510k NumberK212822
Device Name:Disposable Coaxial Biopsy Needle
ClassificationBiopsy Needle
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 CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-03
Decision Date2022-07-06

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