FDA 510(k) Application Details - K210910

Device Classification Name Device, Anti-Snoring

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510(K) Number K210910
Device Name Device, Anti-Snoring
Applicant SnoreBandit LLC
8176 Merlewood Ave
Las Vegas, NV 89117 US
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Contact Garry Thynne
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 03/29/2021
Decision Date 07/01/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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