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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 K935332
Device Name NU.EAR AE-1 IN THE EAR (ITE) HEARING AID
Applicant
Nu-Ear Electronics
10070 Mesa Rim Rd.
San Diego,  CA  92121
Applicant Contact MARK SHAW
Correspondent
Nu-Ear Electronics
10070 Mesa Rim Rd.
San Diego,  CA  92121
Correspondent Contact MARK SHAW
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/05/1993
Decision Date 01/21/1994
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
Predetermined Change
Control Plan Authorized		 No
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