VALVULOTOME BY KOVEN— 510(k) K080178
Substantially EquivalentKoven Technology, Inc.
FDA 510(k) clearance K080178 for VALVULOTOME BY KOVEN, Substantially Equivalent on 2008-07-28. Applicant: Koven Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Koven Technology, Inc.
- Product code
- Code MGZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4885
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
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