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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lenses, soft contact, daily wear
510(k) Number K121519
Device Name ISIGHT
Original Applicant
2214 sanford dr
grand junction,  CO  81505
Original Contact martin dalsing
Regulation Number886.5925
Classification Product Code
Date Received05/22/2012
Decision Date 09/18/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No