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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
Predetermined Change
Control Plan Authorized		 No
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