URESIL VALVE CUTTER— 510(k) K905528
Substantially EquivalentUresil Corp.
FDA 510(k) clearance K905528 for URESIL VALVE CUTTER, Substantially Equivalent on 1991-04-18. Applicant: Uresil Corp.. Device class: 2.
Clearance details
- Applicant
- Uresil Corp.
- Product code
- Code DWQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4885
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skokie, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.