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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K935918
Device Name SPECTACLE FRAME
Applicant
Kenmark Optical Co., Inc.
1825 Cargo Ct.
Louisville,  KY  40299
Applicant Contact MIKE CUNDIFF
Correspondent
Kenmark Optical Co., Inc.
1825 Cargo Ct.
Louisville,  KY  40299
Correspondent Contact MIKE CUNDIFF
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received12/09/1993
Decision Date 02/16/1994
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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