FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT


Device Classification Name

implant, eye sphere

510(k) Number K023400
Device Name FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
Original Applicant
FCI OPHTHALMICS, INC.
344 annabelle point rd.
centerville, 
MA 
02632 -2402

Original Contact hillard w welch
Regulation Number 886.3320
Classification Product Code
HPZ  
Date Received 10/09/2002
Decision Date 08/22/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No