FDA 510(k) Application Details - DEN130039

Device Classification Name

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510(K) Number DEN130039
Device Name BRAINPORT V100 DEVICE
Applicant WICAB, INC
1835 MARKET STREET, 29TH FLOOR
PHILADELPHIA, PA 19103 US
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Contact STEVEN B DATLOF
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Regulation Number

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Classification Product Code PIC
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Date Received 08/07/2013
Decision Date 06/18/2015
Decision DENG -
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review

FDA Source Information for DEN130039


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