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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 K063802
Device Name LENSTEC LC INJECTION SYSTEM
Applicant
LENSTEC, INC.
2870 SCHERER DR., SUITE 300
st. petersburg,  FL  33716
Applicant Contact jimmy chacko
Correspondent
LENSTEC, INC.
2870 SCHERER DR., SUITE 300
st. petersburg,  FL  33716
Correspondent Contact jimmy chacko
Regulation Number886.4300
Classification Product Code
MSS  
Date Received12/22/2006
Decision Date 05/07/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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