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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aid, vision, optical, battery-powered
510(k) Number K884540
Device Name ETV, ELECTRONIC VISION AID
Applicant
SEVRAIN-TECH, INC.
PARK CENTRE
8025 EXCELSIOR DRIVE, SUITE 1
MADISON,  WI  53717
Applicant Contact HEATHER R SCHRAMM
Correspondent
SEVRAIN-TECH, INC.
PARK CENTRE
8025 EXCELSIOR DRIVE, SUITE 1
MADISON,  WI  53717
Correspondent Contact HEATHER R SCHRAMM
Regulation Number886.5915
Classification Product Code
HPE  
Date Received10/28/1988
Decision Date 01/19/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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