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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 K864277
Device Name UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS
Applicant
Unimax Hearing Instruments
1622 W. University Dr.
P.O. Box 782
Denton,  TX  76202
Applicant Contact MAX CHARTRAND
Correspondent
Unimax Hearing Instruments
1622 W. University Dr.
P.O. Box 782
Denton,  TX  76202
Correspondent Contact MAX CHARTRAND
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/30/1986
Decision Date 01/09/1987
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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