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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 K973665
Device Name MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER
Applicant
Magnatone Hearing Aid Corp.
170 N. Cypress Way
P.O. Box 180964
Casselberry,  FL  32718 -0964
Applicant Contact DON E CAMPBELL
Correspondent
Magnatone Hearing Aid Corp.
170 N. Cypress Way
P.O. Box 180964
Casselberry,  FL  32718 -0964
Correspondent Contact DON E CAMPBELL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/25/1997
Decision Date 11/04/1997
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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