EXPRESS MINI GLAUCOMA SHUNT


Device Classification Name

implant, eye valve

510(k) Number K030350
Device Name EXPRESS MINI GLAUCOMA SHUNT
Original Applicant
OPTONOL, LTD
surgical business unit
11460 johns creek parkway
duluth, 
GA 
30097

Original Contact penny northcutt
Regulation Number 886.3920
Classification Product Code
KYF  
Date Received 02/03/2003
Decision Date 03/13/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No