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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
Original Applicant
ALLERGAN, INC.
2525 dupont dr.
p.o. box 19534
irvine,  CA  92623 9534
Original 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 (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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