FDA 510(k) Application Details - DEN200002

Device Classification Name

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510(K) Number DEN200002
Device Name Tangible Boost
Applicant Tangible Science, Inc.
740 Broadway
Redwood City, CA 94063 US
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Contact Kelly Mabry
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Regulation Number

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Classification Product Code QMM
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Date Received 01/13/2020
Decision Date 09/24/2020
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 DEN200002


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