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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 K935331
Device Name NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID
Applicant
NU-EAR ELECTRONICS
10070 MESA RIM RD.
SAN DIEGO,  CA  92121
Applicant Contact MAREK SHAW
Correspondent
NU-EAR ELECTRONICS
10070 MESA RIM RD.
SAN DIEGO,  CA  92121
Correspondent Contact MAREK 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
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