FDA 510(k) Application Details - K092726

Device Classification Name	Mesh Deployment Balloon   More FDA Info for this Device
510(K) Number	K092726
Device Name	Mesh Deployment Balloon
Applicant	SURGICAL STRUCTURES LTD. 1914 J.N. PEASE PLACE CHARLOTTE, NC 28262 US Other 510(k) Applications for this Company
Contact	SHOSH FRIEDMAN Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	OQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2009
Decision Date	03/15/2010
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