EMBRYOGLUE— 510(k) K031015
Substantially EquivalentVitrolife Sweden AB
FDA 510(k) clearance K031015 for EMBRYOGLUE, Substantially Equivalent on 2003-06-23. 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
- Gothenberg, SE
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