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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 K936007
Device Name PRIZM HEARING SYSTEM, MODEL POWER BTE
Applicant
Audioscience, Inc.
5420 Feltl Rd.
Minnetonka,  MN  55343
Applicant Contact DON A ORTON
Correspondent
Audioscience, Inc.
5420 Feltl Rd.
Minnetonka,  MN  55343
Correspondent Contact DON A ORTON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/16/1993
Decision Date 03/04/1994
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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