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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 K970519
Device Name UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
Applicant
Unitron Industries, Inc.
3555 Walnut St.
P.O. Box 5010
Port Huron,  MI  48061 -5010
Applicant Contact JERRY G JOHNSON
Correspondent
Unitron Industries, Inc.
3555 Walnut St.
P.O. Box 5010
Port Huron,  MI  48061 -5010
Correspondent Contact JERRY G JOHNSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/11/1997
Decision Date 04/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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