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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biomicroscope, slit-lamp, ac-powered
510(k) Number K832911
Device Name ABBOTT GLOBE HOLDER
Applicant
MIAMI EYE TECHNOLOGY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MIAMI EYE TECHNOLOGY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1850
Classification Product Code
HJO  
Date Received08/29/1983
Decision Date 09/29/1983
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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