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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 K970828
Device Name UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER
Applicant
United Hearing Systems, Inc.
731-B Norwich Rd.
Plainfield,  CT  06374
Applicant Contact RALPH CAMPAGNA
Correspondent
United Hearing Systems, Inc.
731-B Norwich Rd.
Plainfield,  CT  06374
Correspondent Contact RALPH CAMPAGNA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/06/1997
Decision Date 05/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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