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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, Bone Conduction
510(k) Number K011438
Device Name BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
Applicant
Entific Medical Systems, Inc.
6470 Riverview Ter.
Findley,  MN  55432
Applicant Contact CONSTANCE BUNDY
Correspondent
Entific Medical Systems, Inc.
6470 Riverview Ter.
Findley,  MN  55432
Correspondent Contact CONSTANCE BUNDY
Regulation Number874.3302
Classification Product Code
LXB  
Date Received05/10/2001
Decision Date 07/23/2001
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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