MAIA, MODEL 1— 510(k) K092187
Substantially EquivalentCentervue S.P.A.
FDA 510(k) clearance K092187 for MAIA, MODEL 1, Substantially Equivalent on 2010-05-27. Applicant: Centervue S.P.A.. Device class: 1.
Clearance details
- Applicant
- Centervue S.P.A.
- Product code
- Code HPT
- Device class
- Class 1
- Regulation
- 21 CFR 886.1605
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Padova, IT
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