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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 K844093
Device Name JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR
Applicant
Jcm Labs, Inc.
P.O. Box 366
Nixa,  MO  65714
Applicant Contact JAMES C MURDOCK
Correspondent
Jcm Labs, Inc.
P.O. Box 366
Nixa,  MO  65714
Correspondent Contact JAMES C MURDOCK
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/22/1984
Decision Date 01/29/1985
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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