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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Prescription, Color Deficiency
510(k) Number K984219
Device Name COLORMAX COLOR VISION ENHANCEMENT LENSES
Applicant
Color Vision Technologies, Inc.
19726 Colima Rd.
Suite 320
Rowland Heights,  CA  91748
Applicant Contact JULIE KIM
Correspondent
Color Vision Technologies, Inc.
19726 Colima Rd.
Suite 320
Rowland Heights,  CA  91748
Correspondent Contact JULIE KIM
Regulation Number886.5844
Classification Product Code
NAI  
Date Received11/25/1998
Decision Date 11/18/1999
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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