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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 K002812
Device Name IRIS RETRACTING PHACOEMULSIFICATION SLEEVE
Applicant
Michael Reynard, M.D.
1301-20th St., #260
Santa Monica,  CA  90404
Applicant Contact MICHAEL REYNARD
Correspondent
Michael Reynard, M.D.
1301-20th St., #260
Santa Monica,  CA  90404
Correspondent Contact MICHAEL REYNARD
Regulation Number886.4670
Classification Product Code
HQC  
Date Received09/08/2000
Decision Date 11/08/2000
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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