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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K935420
Device Name SOUNDRIGHT, SHP
Applicant
Soundright Hearing Products
2934a W. Pierce St.
Milwaukee,  WI  53215
Applicant Contact MARK ORLOWSKI
Correspondent
Soundright Hearing Products
2934a W. Pierce St.
Milwaukee,  WI  53215
Correspondent Contact MARK ORLOWSKI
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/09/1993
Decision Date 12/15/1993
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
Predetermined Change
Control Plan Authorized		 No
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