BIOCERAMIC ORBITAL IMPLANT


Device Classification Name

implant, eye sphere

510(k) Number K992294
Device Name BIOCERAMIC ORBITAL IMPLANT
Applicant
FCI OPHTHALMICS, INC.
p.o. box 465
76 prospect st.
marshfield hills, 
MA 
02051

Applicant Contact anne bohsack
Correspondent
FCI OPHTHALMICS, INC.
p.o. box 465
76 prospect st.
marshfield hills, 
MA 
02051

Correspodent Contact anne bohsack
Regulation Number 886.3320
Classification Product Code
HPZ  
Date Received 07/07/1999
Decision Date 04/19/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized