1NEED Pro— 510(k) K243472
Substantially EquivalentCampomats S.R.L.
FDA 510(k) clearance K243472 for 1NEED Pro, Substantially Equivalent on 2025-03-19. Applicant: Campomats S.R.L.. Device class: 2.
Clearance details
- Applicant
- Campomats S.R.L.
- Product code
- Code QAI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4430
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Riccione, IT
Recent devices under product code QAI
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