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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Reading, Television, Closed-Circuit
510(k) Number K915340
Device Name MENTOR HORIZON LOW VISION MAGNIFIER
Applicant
MENTOR O & O, INC.
3000 LONGWATER DR.
NORWELL,  MA  02061 -1672
Applicant Contact RICHARD L FOLLETT
Correspondent
MENTOR O & O, INC.
3000 LONGWATER DR.
NORWELL,  MA  02061 -1672
Correspondent Contact RICHARD L FOLLETT
Regulation Number886.5820
Classification Product Code
HJG  
Date Received10/24/1991
Decision Date 03/30/1992
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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