FDA 510(k) Application Details - K222354

Device Classification Name	More FDA Info for this Device
510(K) Number	K222354
Device Name	Elastic Traction System
Applicant	Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone Nanjing 210032 CN Other 510(k) Applications for this Company
Contact	Sally He Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2022
Decision Date	10/03/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review