FDA 510(k) Application Details - K182380

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K182380
Device Name	Staple, Implantable
Applicant	Lexington Medical, Inc. 11 Executive Park Drive Billerica, MA 01862 US Other 510(k) Applications for this Company
Contact	Douglas MacBride 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	08/31/2018
Decision Date	11/28/2018
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