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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ophthalmic femtosecond laser
510(k) Number K112098
Device Name TBD
Original Applicant
2800 discovery drive
suite 100
orlando,  FL  32826
Original Contact shirley mcgarvey
Regulation Number886.4390
Classification Product Code
Subsequent Product Code
Date Received07/22/2011
Decision Date 10/19/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No