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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Stammering
510(k) Number K800445
Device Name EDINBURGH MASKER
Applicant
FOUNDATION FOR FLUENCY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
FOUNDATION FOR FLUENCY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.5840
Classification Product Code
KTH  
Date Received02/28/1980
Decision Date 03/12/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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