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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 K821042
Device Name MODEL IM9
Applicant
MARCON HEARING INSTRUMENTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MARCON HEARING INSTRUMENTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/14/1982
Decision Date 05/05/1982
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
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