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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 K910744
Device Name PHILIPS MODEL S46-O BTE HEARING AID
Applicant
PHILIPS HEARING INSTRUMENTS CO.
91 MCKEE DR.
MAHWAH,  NJ  07430
Applicant Contact ROBERT MARTIN
Correspondent
PHILIPS HEARING INSTRUMENTS CO.
91 MCKEE DR.
MAHWAH,  NJ  07430
Correspondent Contact ROBERT MARTIN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/21/1991
Decision Date 02/28/1991
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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