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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 K974257
Device Name RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)
Applicant
Resound Corp.
2182 35th Ave., Ct.
Suite 1
Greeley,  CO  80634
Applicant Contact KRISTA M BUCKLES
Correspondent
Resound Corp.
2182 35th Ave., Ct.
Suite 1
Greeley,  CO  80634
Correspondent Contact KRISTA M BUCKLES
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/13/1997
Decision Date 12/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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