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FDA 510(k) Application Details - DEN130039
Device Classification Name
More FDA Info for this Device
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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