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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 K092023
Device Name NAVIJECT SUB2-1P, MODEL: LP604430
Applicant
Medicel AG
377 Rte. 17s
Hasbrouck Heights,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
Medicel AG
377 Rte. 17s
Hasbrouck Heights,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number886.4300
Classification Product Code
MSS  
Date Received07/06/2009
Decision Date 07/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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