INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE


Device Classification Name

unit, phacofragmentation

510(k) Number K112425
Device Name INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
Applicant
ALCON MANUFACTURING, LTD.
15800 alton pkwy.
irvine, 
CA 
92618 -3818

Applicant Contact martin a kaufman
Correspondent
ALCON MANUFACTURING, LTD.
15800 alton pkwy.
irvine, 
CA 
92618 -3818

Correspodent Contact martin a kaufman
Regulation Number 886.4670
Classification Product Code
HQC  
Subsequent Product Codes
HQR   KYB   MLZ  
Date Received 08/23/2011
Decision Date 11/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No