FDA 510(k) Application Details - K171561

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K171561
Device Name	Staple, Implantable
Applicant	Dextera Surgical Inc. 900 Saginaw Drive Redwood City, CA 94063 US Other 510(k) Applications for this Company
Contact	Greg Watson 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	05/30/2017
Decision Date	08/28/2017
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