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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 K852244
Device Name HEARING AID(ALL IN EAR)
Applicant
OLYMPIA INSTRUMENTS, INC.
1499 S. HWY. 17-92
LONGWOOD,  FL  32750
Applicant Contact FRANCIS C MUTO
Correspondent
OLYMPIA INSTRUMENTS, INC.
1499 S. HWY. 17-92
LONGWOOD,  FL  32750
Correspondent Contact FRANCIS C MUTO
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/23/1985
Decision Date 11/07/1985
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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