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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 K122848
Device Name LENSTEC LC INJECTION SYSTEM
Applicant
Lenstec, Inc.
1765 Commerce Ave. N.,
St. Petersburg,  FL  33716
Applicant Contact JIMMY CHACKO
Correspondent
Bsi Healthcare
Kitemark Court, Davy Ave.
Knowlhill
Milton Keynes,  GB MK5 8PP
Correspondent Contact JOHN HOWLETT
Regulation Number886.4300
Classification Product Code
MSS  
Date Received09/18/2012
Decision Date 10/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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