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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, phacofragmentation
510(k) Number K003638
Device Name MOJAVE CATARACT EXTRACTION SYSTEM
Applicant
ALLERGAN, INC.
2525 DUPONT DR.
P.O. BOX 19534
IRVINE,  CA  92623 -9534
Applicant Contact MARK O'DONNELL
Correspondent
ALLERGAN, INC.
2525 DUPONT DR.
P.O. BOX 19534
IRVINE,  CA  92623 -9534
Correspondent Contact MARK O'DONNELL
Regulation Number886.4670
Classification Product Code
HQC  
Date Received11/24/2000
Decision Date 02/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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