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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, temperature measurement, direct contact, powered
510(k) Number K821107
Device Name EXOPHTHALMOMETER
Applicant
MEDICAL EQUIPMENT DESIGNS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDICAL EQUIPMENT DESIGNS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1570
Classification Product Code
HCS  
Date Received04/20/1982
Decision Date 06/14/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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