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FDA 510(k) Application Details - DEN240064
Device Classification Name
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510(K) Number
DEN240064
Device Name
CT-132
Applicant
Click Therapeutics, Inc.
80 White St
3rd Floor
New York, NY 10013 US
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Contact
Dr. Shaheen Lakhan
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Regulation Number
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Classification Product Code
SEE
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Date Received
11/12/2024
Decision Date
04/11/2025
Decision
DENG -
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
FDA Source Information for DEN240064
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