FDA 510(k) Application Details - K190677

Device Classification Name	More FDA Info for this Device
510(K) Number	K190677
Device Name	EndoClot
Applicant	EndoClot Plus Co., Ltd. 101 Room, B8 Building, 218 Xinghu Street Suzhou Industrial Park SuZhou 215000 CN Other 510(k) Applications for this Company
Contact	Huihui Xie Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2019
Decision Date	01/29/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review