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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chart, Visual Acuity
510(k) Number K880647
Device Name ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)
Applicant
FRED SAMMONS, INC.
145 TOWER DR.
BURR RIDGE,  IL  60521
Applicant Contact SUSAN BLEDSOE
Correspondent
FRED SAMMONS, INC.
145 TOWER DR.
BURR RIDGE,  IL  60521
Correspondent Contact SUSAN BLEDSOE
Regulation Number886.1150
Classification Product Code
HOX  
Date Received02/16/1988
Decision Date 04/01/1988
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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