KARATS MULTIPURPOSE SOLUTION


Device Classification Name

accessories, soft lens products

510(k) Number K021635
Device Name KARATS MULTIPURPOSE SOLUTION
Original Applicant
CIBA VISION CORPORATION
11460 johns creek pkwy.
duluth, 
GA 
30097

Original Contact steven dowdley
Regulation Number 886.5928
Classification Product Code
LPN  
Date Received 05/17/2002
Decision Date 10/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No