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510(k) Data Aggregation
K Number
K970308Device Name
MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE
Manufacturer
MENTOR UROLOGY, INC.
Date Cleared
1997-04-02
(65 days)
Product Code
FHA
Regulation Number
876.5160Why did this record match?
Applicant Name (Manufacturer) :
MENTOR UROLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is indicated for any male, who has urinary incontinence, either on a temporary or long term basis. It is also indicated for those patients who have an adverse reaction to natural latex rubber.
Device Description
The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is a two piece compression device for males with urinary incontinence. The device consists of a silicone gel filled penile compression wrap for occlusion of the urethra and a silicone ring. It is intended for users who would prefer a reusable soft sided device instead of a rigid clamping device. The device is intended for users with moderate to heavy urinary incontinence to provide a temporary means of urinary continence.
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