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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Electronic Vision Aid
510(k) Number K152851
Device Name BrainPort V100
Applicant
Wicab, Inc.
8313 Greenway Blvd., Suite 100
Middleton,  WI  53562
Applicant Contact ROBERT BECKMAN
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact STEVEN B DATLOF
Regulation Number886.5905
Classification Product Code
PIC  
Date Received09/29/2015
Decision Date 12/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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