FDA 510(k) Application Details - K111337

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K111337
Device Name	Mesh, Surgical, Polymeric
Applicant	TORNIER, INC. 7701 FRANCE AVE SOUTH SUITE 600 EDINA, MN 55435 US Other 510(k) Applications for this Company
Contact	HOWARD L SCHRAYER Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2011
Decision Date	01/25/2012
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