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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K872312
Device Name MODEL 3000 OPHTHALMIC SURGICAL SYSTEM
Applicant
ALLERGAN HUMPHREY
3081 TEAGARDEN ST.
SAN LEANDRO,  CA  94577
Applicant Contact BERRY DODD
Correspondent
ALLERGAN HUMPHREY
3081 TEAGARDEN ST.
SAN LEANDRO,  CA  94577
Correspondent Contact BERRY DODD
Regulation Number886.4150
Classification Product Code
HQE  
Date Received04/14/1987
Decision Date 07/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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