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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Folders And Injectors, Intraocular Lens (Iol)
510(k) Number K002556
Device Name CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
Applicant
Pharmacia & Upjohn Co.
592 Ceresia Ct.
Pickerington,,  OH  43147
Applicant Contact TONI D ELLIOTT
Correspondent
Pharmacia & Upjohn Co.
592 Ceresia Ct.
Pickerington,,  OH  43147
Correspondent Contact TONI D ELLIOTT
Regulation Number886.4300
Classification Product Code
MSS  
Date Received08/17/2000
Decision Date 10/31/2000
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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