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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Selector, Color, Spectacle, Lens, Tint
510(k) Number K012298
Device Name THE INTUITIVE COLORIMETER
Applicant
Cerium Optical Technologies, Inc.
36 Bradford Rd.
Natick,  MA  01760
Applicant Contact SOL AISENBERG
Correspondent
Cerium Optical Technologies, Inc.
36 Bradford Rd.
Natick,  MA  01760
Correspondent Contact SOL AISENBERG
Regulation Number886.1160
Classification Product Code
NFD  
Date Received07/20/2001
Decision Date 09/26/2001
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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