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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 K974338
Device Name UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
Applicant
Unitron Industries, Inc.
3555 Walnut St.
P.O. Box 5010
Port Huron,  MI  48061
Applicant Contact SUSAN ARCHER
Correspondent
Unitron Industries, Inc.
3555 Walnut St.
P.O. Box 5010
Port Huron,  MI  48061
Correspondent Contact SUSAN ARCHER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/18/1997
Decision Date 12/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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