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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K924032
Device Name CORNEAL ANALYSIS SYSTEMS(TM)
Applicant
Eyesys Laboratories, Inc.
2776 Bingle Rd.
Houston,  TX  77055
Applicant Contact KENNETH CARBONARI
Correspondent
Eyesys Laboratories, Inc.
2776 Bingle Rd.
Houston,  TX  77055
Correspondent Contact KENNETH CARBONARI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/11/1992
Decision Date 03/18/1993
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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