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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Guide, Intraocular
510(k) Number K070669
Device Name IOL INJECTOR SET
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
KYB  
Date Received03/12/2007
Decision Date 11/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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