FDA 510(k) Applications for Medical Device Product Code "MNG"
(External Urethral Occluder, Urinary Incontinence-Control, Female)

FDA 510(k) Number Applicant Device Name Decision Date
K954215 ADVANCED SURGICAL INTERVENTION, INC. MINIGUARD 05/08/1996
K974645 INSIGHT MEDICAL CORP. FEMASSIST FLEXIBLE 02/12/1998
K963858 INSIGHT MEDICAL CORP. FEMASSIST URINARY DEVICE 10/21/1997
K971359 NEBL, INC. RESTORE (A.K.A. CAPSURE) 11/14/1997
K983164 NEBL, INC. RESTORE (AKA RE/STOR) 03/05/1999
K010365 PERSONAL PRODUCTS CO. ORTHO CONTROL FEMALE URINARY CONTROL DEVICE 04/30/2001
K974600 UROMED CORP. UROMED PATCH 03/31/1998


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact