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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 K952228
Device Name SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE
Applicant
Resound Corp.
220 Saginaw Dr.,
Seaport Centre
Redwood City,  CA  94063
Applicant Contact KRISTA M BUCKLES
Correspondent
Resound Corp.
220 Saginaw Dr.,
Seaport Centre
Redwood City,  CA  94063
Correspondent Contact KRISTA M BUCKLES
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/11/1995
Decision Date 06/05/1995
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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