RAPIDVIT AND RAPIDWARM CLEAVE— 510(k) K080446
Substantially EquivalentVitrolife Sweden AB
FDA 510(k) clearance K080446 for RAPIDVIT AND RAPIDWARM CLEAVE, Substantially Equivalent on 2008-11-26. Applicant: Vitrolife Sweden AB. Device class: 2.
Clearance details
- Applicant
- Vitrolife Sweden AB
- Product code
- Code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kungsbacka, SE
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