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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transilluminator, ac-powered
510(k) Number K811108
Device Name RMI TRANSILLUMINATION LIGHT METER #295
Applicant
RADIATION MEASUREMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RADIATION MEASUREMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1945
Classification Product Code
HJM  
Date Received04/23/1981
Decision Date 07/01/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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