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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 K903862
Device Name ITE HEARING AID, SOUND MED RUBY MODEL
Applicant
Improved Hearing Service, Inc.
2525 A E. Bell Rd.
Phoenix,  AZ 
Applicant Contact RUDISILL II
Correspondent
Improved Hearing Service, Inc.
2525 A E. Bell Rd.
Phoenix,  AZ 
Correspondent Contact RUDISILL II
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/30/1990
Decision Date 10/09/1990
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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