GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K003071
Device Name GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Original Applicant
CIBA VISION CORPORATION
11460 johns creek pkwy.
duluth, 
GA 
30097

Original Contact terrina wilder
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 10/02/2000
Decision Date 12/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Special
Reviewed by Third Party No

Combination Product

No