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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 K891916
Device Name ITE PRESCRIPTION SERIES MODEL PP + F
Applicant
US HEARING CENTERS, INC.
4750 SO. MILE HIGH DR.
SALT LAKE CITY,  UT  84124 -4753
Applicant Contact JACK I DAHL
Correspondent
US HEARING CENTERS, INC.
4750 SO. MILE HIGH DR.
SALT LAKE CITY,  UT  84124 -4753
Correspondent Contact JACK I DAHL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/27/1989
Decision Date 07/14/1989
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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