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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
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