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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
Applicant
C & E GP SPECIALISTS, INC.
2214 SANFORD DR
GRAND JUNCTION,  CO  81505
Applicant Contact MARTIN DALSING
Correspondent
C & E GP SPECIALISTS, INC.
2214 SANFORD DR
GRAND JUNCTION,  CO  81505
Correspondent Contact MARTIN DALSING
Regulation Number886.5925
Classification Product Code
LPL  
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
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