FDA 510(k) Application Details - K192330

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K192330
Device Name	Staple, Implantable
Applicant	Covidien Rooms 501, 502, 601, 602, No.3 building No.2388 Chen Hang Road Min Hang District, Shanghai 201114 CN Other 510(k) Applications for this Company
Contact	Sarah Tang 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	08/27/2019
Decision Date	01/23/2020
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