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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 K002913
FOIA Releasable 510(k) K002913
Device Name HEADBAND FOR BAHA
Applicant
ENTIFIC MEDICAL SYSTEMS, INC.
6470 RIVERVIEW TERRACE
MINNEAPOLIS,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
ENTIFIC MEDICAL SYSTEMS, INC.
6470 RIVERVIEW TERRACE
MINNEAPOLIS,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number874.3302
Classification Product Code
LXB  
Date Received09/18/2000
Decision Date 10/17/2000
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
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