SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)— 510(k) K173731
Substantially EquivalentCooperSurgical, Inc.
FDA 510(k) clearance K173731 for SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031), Substantially Equivalent on 2018-03-02. Applicant: CooperSurgical, Inc.. Device class: 2.
Clearance details
- Applicant
- CooperSurgical, Inc.
- 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
- Trumbull, CT, US
Recent devices under product code MQL
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