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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 K942107
Device Name MAGIC EAR, ELAIN
Applicant
Novaplex, Inc.
8818 Bradley Ave.
Sun Valley,  CA  91352
Applicant Contact WILLIAM PREVOST
Correspondent
Novaplex, Inc.
8818 Bradley Ave.
Sun Valley,  CA  91352
Correspondent Contact WILLIAM PREVOST
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/02/1994
Decision Date 02/08/1995
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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