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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 K854225
Device Name ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS
Applicant
Advanced Medical Technology, Inc.
Westhaven Bldgl - Suite 201
15751 Brookhurst St.
Westminister,  CA  92683
Applicant Contact THOMAS V KEELEY
Correspondent
Advanced Medical Technology, Inc.
Westhaven Bldgl - Suite 201
15751 Brookhurst St.
Westminister,  CA  92683
Correspondent Contact THOMAS V KEELEY
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/18/1985
Decision Date 12/27/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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