MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE— 510(k) K970308
Substantially EquivalentMentor Urology, Inc.
FDA 510(k) clearance K970308 for MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE, Substantially Equivalent on 1997-04-02. Applicant: Mentor Urology, Inc.. Device class: 1.
Clearance details
- Applicant
- Mentor Urology, Inc.
- Product code
- Code FHA
- Device class
- Class 1
- Regulation
- 21 CFR 876.5160
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code FHA
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