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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 K944043
Device Name BTP-A HEARING SYSTEM
Applicant
RESOUND CORP.
220 SAGINAW DRIVE,
SEAPORT CENTRE
REDWOOD CITY,  CA  94063
Applicant Contact JEANNETTE S JOHNSON
Correspondent
RESOUND CORP.
220 SAGINAW DRIVE,
SEAPORT CENTRE
REDWOOD CITY,  CA  94063
Correspondent Contact JEANNETTE S JOHNSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/18/1994
Decision Date 12/23/1994
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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