BIOCERAMIC ORBITAL IMPLANT— 510(k) K992294

Substantially Equivalent

Fci Ophthalmics, Inc.

FDA 510(k) clearance K992294 for BIOCERAMIC ORBITAL IMPLANT, Substantially Equivalent on 2000-04-19. Applicant: Fci Ophthalmics, Inc..

Clearance details

Applicant: Fci Ophthalmics, Inc.
Product code: Code HPZ
Advisory panel: Ophthalmic
Date received: 1999-07-07
Decision date: 2000-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marshfield Hills, MA, US

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