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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 K852451
Device Name RIONET HEARING AID HB-34HT
Applicant
Rion Acoustic Instruments, Inc.
555 S. Flower St.
26th. Floor
Los Angeles,  CA  90017
Applicant Contact RICHARD G WALLACE
Correspondent
Rion Acoustic Instruments, Inc.
555 S. Flower St.
26th. Floor
Los Angeles,  CA  90017
Correspondent Contact RICHARD G WALLACE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/10/1985
Decision Date 08/21/1985
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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