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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 K882005
Device Name HARMONY HEARING AID MODELS LP, M, HO, HF, & C
Applicant
Harmony Hearing Aids, Co.
9425 Olde Eight Rd.
Northfield Center,  OH  44067
Applicant Contact GERALD A BLOCH
Correspondent
Harmony Hearing Aids, Co.
9425 Olde Eight Rd.
Northfield Center,  OH  44067
Correspondent Contact GERALD A BLOCH
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/13/1988
Decision Date 07/12/1988
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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