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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 K973861
Device Name FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48
Applicant
Magnatone Hearing Aid Corp.
P.O. Box 180964
Casselberry,  FL  32718 -0964
Applicant Contact DON E K. CAMPBELL
Correspondent
Magnatone Hearing Aid Corp.
P.O. Box 180964
Casselberry,  FL  32718 -0964
Correspondent Contact DON E K. CAMPBELL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/09/1997
Decision Date 11/19/1997
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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