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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 K971804
Device Name PHILIPS S1694, S1695
Applicant
PHILIPS HEARING INSTRUMENTS CO.
91 MCKEE DR.
MAHWAH,  NJ  07430
Applicant Contact TED MIKSIEWICZ
Correspondent
PHILIPS HEARING INSTRUMENTS CO.
91 MCKEE DR.
MAHWAH,  NJ  07430
Correspondent Contact TED MIKSIEWICZ
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/14/1997
Decision Date 06/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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