Fetal Pillow— 510(k) K243799
Substantially EquivalentCooperSurgical, Inc.
FDA 510(k) clearance K243799 for Fetal Pillow, Substantially Equivalent on 2025-08-29. Applicant: CooperSurgical, Inc.. Device class: 2.
Clearance details
- Applicant
- CooperSurgical, Inc.
- Product code
- Code PWB
- Device class
- Class 2
- Regulation
- 21 CFR 884.4350
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Trumbull, CT, US
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