DETRUSAN 500— 510(k) K994109
Substantially EquivalentInnovamed USA, Inc.
FDA 510(k) clearance K994109 for DETRUSAN 500, Substantially Equivalent on 2000-08-03. Applicant: Innovamed USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Innovamed USA, Inc.
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lehigh Acres, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.