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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 K936190
Device Name BEHIND THE EAR HEARING AID
Applicant
AUDINA HEARING INSTRUMENT
150 E WILDMERE ST.
P.O. BOX 877
CASSELBERRY,  FL  32750
Applicant Contact FRANK J ROBILOTTA
Correspondent
AUDINA HEARING INSTRUMENT
150 E WILDMERE ST.
P.O. BOX 877
CASSELBERRY,  FL  32750
Correspondent Contact FRANK J ROBILOTTA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/27/1993
Decision Date 04/04/1994
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
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