FDA 510(k) Application Details - K211937

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K211937
Device Name	Sleeve, Limb, Compressible
Applicant	Jiangsu Synecoun Medical Technology Co., Ltd. 1/2F East Side,No. 50, G60, Eastside of Lujia Road, West of Koutai Road, China Medical City Taizhou 225300 CN Other 510(k) Applications for this Company
Contact	Zhheng Li Other 510(k) Applications for this Contact
Regulation Number	870.5800   More FDA Info for this Regulation Number
Classification Product Code	JOW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2021
Decision Date	11/18/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review