FDA 510(k) Application Details - K181620

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K181620
Device Name	Staple, Implantable
Applicant	Ezisurg (Suzhou) Medical Co., Ltd. Building 16, No. 8 Jinfeng Rd., Suzhou National Hi-Tech District Suzhou 215163 CN Other 510(k) Applications for this Company
Contact	Renjing Tian Other 510(k) Applications for this Contact
Regulation Number	878.4750   More FDA Info for this Regulation Number
Classification Product Code	GDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2018
Decision Date	09/18/2018
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