FDA 510(k) Application Details - DEN200017

Device Classification Name

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510(K) Number DEN200017
Device Name Q-Collar
Applicant Q30 Sports Science, LLC
257 Riverside Avenue
Westport, CT 06880 US
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Contact Gary A. Greene
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Regulation Number

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Classification Product Code QNX
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Date Received 03/19/2020
Decision Date 02/26/2021
Decision DENG -
Classification Advisory Committee NE - Neurology
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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