CooperSurgical Advincula Delineator Uterine Manipulator— 510(k) K143650
Substantially EquivalentCooperSurgical, Inc.
FDA 510(k) clearance K143650 for CooperSurgical Advincula Delineator Uterine Manipulator, Substantially Equivalent on 2015-07-21. Applicant: CooperSurgical, Inc.. Device class: 2.
Clearance details
- Applicant
- CooperSurgical, Inc.
- Product code
- Code HEW
- Device class
- Class 2
- Regulation
- 21 CFR 884.1640
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Trumbull, CT, US
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