FDA 510(k) Application Details - K163217

Device Classification Name	More FDA Info for this Device
510(K) Number	K163217
Device Name	GORE BIO-A Tissue Reinforcement
Applicant	W. L. GORE & ASSOCIATES, INC. 301 Airport Rd. PO BOX 1408 Elkton, MD 21922-1408 US Other 510(k) Applications for this Company
Contact	Barbara L Smith Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2016
Decision Date	02/10/2017
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