FDA 510(k) Application Details - K131658

Device Classification Name	More FDA Info for this Device
510(K) Number	K131658
Device Name	GORE SEAMGUARD REINFORCEMENT
Applicant	W. L. GORE & ASSOCIATES, INC. 301 AIRPORT RD. ELKTON, MD 21921 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	OXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2013
Decision Date	09/06/2013
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