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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, Non-Custom (Prescription)
510(k) Number K843096
Device Name CRISTY/COTE
Applicant
Titmus Optical, Inc.
Petersburg,  VA  23804
Correspondent
Titmus Optical, Inc.
Petersburg,  VA  23804
Regulation Number886.5844
Classification Product Code
HQG  
Date Received08/07/1984
Decision Date 11/21/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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