NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON


Device Classification Name

button, iris, eye, artificial

510(k) Number K001326
Device Name NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
Original Applicant
OCULAR CONCEPTS LLC.
4035 sw mercantile dr.
suite 208
portland, 
OR 
97035 -2591

Original Contact kevin schou
Regulation Number 886.3200
Classification Product Code
NCK  
Date Received 04/26/2000
Decision Date 06/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No