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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, irrigation, ocular surgery
510(k) Number K981116
Device Name SOVEREIGN CATARACT EXTRACTION SYSTEM
Applicant
ALLERGAN, INC.
2525 DUPONT DR.
P.O. BOX 19534
IRVINE,  CA  92623 -9534
Applicant Contact MARCIA S YAROSS, PH,D.
Correspondent
ALLERGAN, INC.
2525 DUPONT DR.
P.O. BOX 19534
IRVINE,  CA  92623 -9534
Correspondent Contact MARCIA S YAROSS, PH,D.
Regulation Number886.4360
Classification Product Code
KYG  
Date Received03/27/1998
Decision Date 05/19/1998
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
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