FDA 510(k) Application Details - K132397

Device Classification Name	More FDA Info for this Device
510(K) Number	K132397
Device Name	GORE BIO-A WOUND MATRIX
Applicant	W. L. GORE & ASSOCIATES, INC. 301 AIRPORT RD. ELKTON, MD 21921 US Other 510(k) Applications for this Company
Contact	BARBARA L SMITH, RAC Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2013
Decision Date	05/07/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review