BIOCERAMIC ORBITAL IMPLANT— 510(k) K992294
Substantially EquivalentFci Ophthalmics, Inc.
FDA 510(k) clearance K992294 for BIOCERAMIC ORBITAL IMPLANT, Substantially Equivalent on 2000-04-19. Applicant: Fci Ophthalmics, Inc.. Device class: 2.
Clearance details
- Applicant
- Fci Ophthalmics, Inc.
- Product code
- Code HPZ
- Device class
- Class 2
- Regulation
- 21 CFR 886.3320
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marshfield Hills, MA, US
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