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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name face plate hearing aid
510(k) Number K942236
Device Name AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)
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
LRB  
Date Received05/09/1994
Decision Date 06/17/1994
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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