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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 K874369
Device Name CONCHA, CAVUM, CANAL, CONCHA-P HEARING AID
Applicant
ALTAMONTE HEARING CLINIC
FRC BUILDING, SUITE #207
101 WYMORE ROAD
ALTAMONTE SPRINGS,  FL  32701
Applicant Contact A CHARI,PHD
Correspondent
ALTAMONTE HEARING CLINIC
FRC BUILDING, SUITE #207
101 WYMORE ROAD
ALTAMONTE SPRINGS,  FL  32701
Correspondent Contact A CHARI,PHD
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/26/1987
Decision Date 01/19/1988
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
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