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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 K944009
Device Name HEARING AID (ACCESSORY)
Applicant
Phoenix Management, Inc.
5195 Fontaine Blvd.
Fountain,  CO  80817
Applicant Contact JO WALDRON
Correspondent
Phoenix Management, Inc.
5195 Fontaine Blvd.
Fountain,  CO  80817
Correspondent Contact JO WALDRON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/16/1994
Decision Date 11/22/1994
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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