MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME

Device Classification Name

keratome, ac-powered

510(k) Number K032978
Device Name MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
Applicant
CIBA VISION CORPORATION
11460 johns creek pkwy.
duluth, 
GA 
30097

Applicant Contact penny northcutt
Correspondent
CIBA VISION CORPORATION
11460 johns creek pkwy.
duluth, 
GA 
30097

Correspodent Contact penny northcutt
Regulation Number 886.4370
Classification Product Code
HNO  
Subsequent Product Code
HOG  
Date Received 09/24/2003
Decision Date 10/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No