BIOCERAMIC ORBITAL IMPLANT, ORBTEX


Device Classification Name

implant, eye sphere

510(k) Number K110554
Device Name BIOCERAMIC ORBITAL IMPLANT, ORBTEX
Applicant
CERAMISYS LTD.
344 annabelle point road
centercille, 
MA 
02632 -2402

Applicant Contact hillard w welch
Correspondent
CERAMISYS LTD.
344 annabelle point road
centercille, 
MA 
02632 -2402

Correspodent Contact hillard w welch
Regulation Number 886.3320
Classification Product Code
HPZ  
Date Received 02/28/2011
Decision Date 11/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No