SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM


Device Classification Name

unit, phacofragmentation

510(k) Number K111446
Device Name SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
Applicant
ABBOTT MEDICAL OPTICS INC
1700 east saint andrew pl
santa ana, 
CA 
92705

Applicant Contact rosanne m yetemian
Correspondent
ABBOTT MEDICAL OPTICS INC
1700 east saint andrew pl
santa ana, 
CA 
92705

Correspodent Contact rosanne m yetemian
Regulation Number 886.4670
Classification Product Code
HQC  
Date Received 05/24/2011
Decision Date 12/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls