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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 K943670
Device Name MO6 SERIES
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 Received07/26/1994
Decision Date 08/18/1994
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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