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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K843304
Device Name BINOCULAR INDIRECT OPHTHALMOSCOPE
Applicant
Mentor O & O, Inc.
South Shore Park
Hingham,  MA  02043
Applicant Contact DAVID M LINK
Correspondent
Mentor O & O, Inc.
South Shore Park
Hingham,  MA  02043
Correspondent Contact DAVID M LINK
Regulation Number886.1570
Classification Product Code
HLI  
Date Received08/23/1984
Decision Date 11/21/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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