DURETTE IMPLANT


Device Classification Name

implant, eye sphere

510(k) Number K073293
Device Name DURETTE IMPLANT
Applicant
OCULO PLASTIK, INC.
200 sauve west
montreal, qc, 

CA

h3l 1y9

Applicant Contact jean-francois durette
Correspondent
OCULO PLASTIK, INC.
200 sauve west
montreal, qc, 

CA

h3l 1y9

Correspodent Contact jean-francois durette
Regulation Number 886.3320
Classification Product Code
HPZ  
Date Received 11/23/2007
Decision Date 03/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No