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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 K901569
Device Name BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL
Applicant
Unitron Industries, Inc.
3555 Walnut St.
P.O. Box 5010
Port Huron,  MI  48061
Applicant Contact JERRY G JOHNSON
Correspondent
Unitron Industries, Inc.
3555 Walnut St.
P.O. Box 5010
Port Huron,  MI  48061
Correspondent Contact JERRY G JOHNSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/04/1990
Decision Date 04/18/1990
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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