FDA 510(k) Application Details - K101440

Device Classification Name	More FDA Info for this Device
510(K) Number	K101440
Device Name	GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012
Applicant	GENERIC MEDICAL DEVICES, 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	05/24/2010
Decision Date	06/18/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review