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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 K915076
Device Name MED-EQUIP CORPORATION
Applicant
Medequip Co.
1040 S.King St.
Honolulu,  HI  96814
Applicant Contact HOWARD K.TAMASHIRO
Correspondent
Medequip Co.
1040 S.King St.
Honolulu,  HI  96814
Correspondent Contact HOWARD K.TAMASHIRO
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/08/1991
Decision Date 01/09/1992
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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