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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 K920134
Device Name PHILIPS 41 SERIES RAINBOW
Applicant
PHILIPS INT'L B.V.
91 MCKEE DR.
MAHWAH,  NJ  07430
Applicant Contact ROBERT MARTIN
Correspondent
PHILIPS INT'L B.V.
91 MCKEE DR.
MAHWAH,  NJ  07430
Correspondent Contact ROBERT MARTIN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/13/1992
Decision Date 01/24/1992
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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