SAGE Vitrification Kit and SAGE Vitrification Warming Kit— 510(k) K170560
Substantially EquivalentCooperSurgical, Inc.
FDA 510(k) clearance K170560 for SAGE Vitrification Kit and SAGE Vitrification Warming Kit, Substantially Equivalent on 2017-04-04. 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
- Special
- Location
- Trumbull, CT, US
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