FDA 510(k) Application Details - K212819

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K212819
Device Name	Kit, Needle, Biopsy
Applicant	Suzhou Leapmed Healthcare Corporation Wuzhong Science Park, NO.2 & NO.3 Building 38# North Guandu Road, Wuzhong District Suzhou 215100 CN Other 510(k) Applications for this Company
Contact	Yu Zhu Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	FCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2021
Decision Date	07/06/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review