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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photostimulator, Ac-Powered
510(k) Number K830770
Device Name CONTRAST SENSITIVITY EQUIPMENT
Applicant
CADWELL LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CADWELL LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1630
Classification Product Code
HLX  
Date Received03/11/1983
Decision Date 04/28/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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