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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pupillometer, ac-powered
510(k) Number K802351
Device Name F110 PHOTO BINOCULAR OPHTHALMOSCOPE
Applicant
MINAMI, TOMINE & LEW
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MINAMI, TOMINE & LEW
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1700
Classification Product Code
HLG  
Date Received09/25/1980
Decision Date 12/17/1980
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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