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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle (Prescription), For Reading Discomfort
510(k) Number K022373
Device Name CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
Applicant
Cantor & Nissel , Ltd.
623 Glacier Dr.
Grand Junction,  CO  81503
Applicant Contact MARTIN DALSING
Correspondent
Cantor & Nissel , Ltd.
623 Glacier Dr.
Grand Junction,  CO  81503
Correspondent Contact MARTIN DALSING
Regulation Number886.5844
Classification Product Code
NJH  
Subsequent Product Codes
HQG   NAI  
Date Received07/22/2002
Decision Date 10/07/2002
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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