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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 K972039
Device Name NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)
Applicant
NU-SOUND
2501 WEST MEMORIAL
QUAIL SPRINGS MALL
OKLAHOMA CITY,  OK  73134
Applicant Contact WAVA BRIANS
Correspondent
NU-SOUND
2501 WEST MEMORIAL
QUAIL SPRINGS MALL
OKLAHOMA CITY,  OK  73134
Correspondent Contact WAVA BRIANS
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/02/1997
Decision Date 08/25/1997
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
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