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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 K882721
Device Name ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR
Applicant
HEAR-O INC. C/O L.P. LEALE & ASSOC.
1849 BONANAZA ST.
WALNUT CREEK,  CA  94596
Applicant Contact L. P LEALE
Correspondent
HEAR-O INC. C/O L.P. LEALE & ASSOC.
1849 BONANAZA ST.
WALNUT CREEK,  CA  94596
Correspondent Contact L. P LEALE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/01/1988
Decision Date 09/15/1988
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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