SILICONE SPHERES


Device Classification Name

implant, eye sphere

510(k) Number K112176
Device Name SILICONE SPHERES
Applicant
OCULO PLASTIK, INC.
200 sauve west
montreal, qc, 

CA

h3l 1y9

Applicant Contact sylvain desrosiers
Correspondent
OCULO PLASTIK, INC.
200 sauve west
montreal, qc, 

CA

h3l 1y9

Correspodent Contact sylvain desrosiers
Regulation Number 886.3320
Classification Product Code
HPZ  
Date Received 07/28/2011
Decision Date 09/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No