FDA 510(k) Application Details - K112423

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K112423
Device Name	Mesh, Surgical
Applicant	ROTATION MEDICAL, INC. 15350 25TH AVENUE N SUITE 100 PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	JEFF SIMS Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2011
Decision Date	12/22/2011
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