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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, Tactile
510(k) Number K883853
Device Name ETA
Applicant
Sevrain-Tech, Inc.
Park Centre
8025 Excelsior Dr., Suite 1
Madison,  WI  53717
Applicant Contact HEATHER R SCHRAMM
Correspondent
Sevrain-Tech, Inc.
Park Centre
8025 Excelsior Dr., Suite 1
Madison,  WI  53717
Correspondent Contact HEATHER R SCHRAMM
Classification Product Code
LRA  
Date Received09/13/1988
Decision Date 11/17/1988
Decision Substantially Equivalent (SESE)
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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