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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 ROUTE 17 S
HASBROUCK HEIGHTS,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
MEDICEL AG
377 ROUTE 17 S
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
Recalls CDRH Recalls
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