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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 K893004
Device Name HEARING AID (ALL-IN-THE-EAR)
Applicant
HEARING SPECIALISTS OF NEVADA, INC.
2415 E. TROPICANA
LAS VEGAS,  NV  89121
Applicant Contact FRANK MUTO
Correspondent
HEARING SPECIALISTS OF NEVADA, INC.
2415 E. TROPICANA
LAS VEGAS,  NV  89121
Correspondent Contact FRANK MUTO
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/24/1989
Decision Date 03/14/1990
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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