FDA 510(k) Application Details - K111219

Device Classification Name	More FDA Info for this Device
510(K) Number	K111219
Device Name	GMD UNIVERSAL URINARY INCONTINENCE SLING
Applicant	GENERIC MEDICAL DEVICE, INC. PO BOX 818 OCEAN SHORES, WA 98569 US Other 510(k) Applications for this Company
Contact	JEFF MORGAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2011
Decision Date	06/30/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review