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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 K894176
Device Name FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA
Applicant
Precision Hearing Instruments
P.O. Box 5362
Rocky Point,  NY  11778
Applicant Contact LAURENCE J EMERY
Correspondent
Precision Hearing Instruments
P.O. Box 5362
Rocky Point,  NY  11778
Correspondent Contact LAURENCE J EMERY
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/15/1989
Decision Date 11/03/1989
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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