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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 K933633
Device Name LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE
Applicant
GRACEFULLY YOURS, INC.
12527 ULMERTON RD.
LARGO,  FL  34644
Applicant Contact JAMES F TURNER III
Correspondent
GRACEFULLY YOURS, INC.
12527 ULMERTON RD.
LARGO,  FL  34644
Correspondent Contact JAMES F TURNER III
Regulation Number886.5820
Classification Product Code
HJG  
Date Received07/27/1993
Decision Date 02/22/1994
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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