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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact, For Color Vision Deficiency
510(k) Number K994320
Device Name CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES
Applicant
Cantor & Silver , Ltd.
623 Glacier Dr.
Grand Junction,  CO  81503
Applicant Contact MARTIN DALSING
Correspondent
Cantor & Silver , Ltd.
623 Glacier Dr.
Grand Junction,  CO  81503
Correspondent Contact MARTIN DALSING
Regulation Number886.5925
Classification Product Code
NCZ  
Date Received12/22/1999
Decision Date 10/20/2000
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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