FDA 510(k) Application Details - K171357

Device Classification Name	More FDA Info for this Device
510(K) Number	K171357
Device Name	SurgiMend PRS Meshed, Revize-X
Applicant	Integra LifeSciences Corporation (Owner of TEI Biosciences) 7 Elkins Street Boston, MA 02127 US Other 510(k) Applications for this Company
Contact	Kavita Amin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2017
Decision Date	06/07/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review