FDA 510(k) Application Details - K221322

Device Classification Name Device, Anti-Snoring

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510(K) Number K221322
Device Name Device, Anti-Snoring
Applicant Dental Choice Holdings LLC
10100 Linn Station Road
Louisville, KY 40223 US
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Contact Danielle M Jackson
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 05/06/2022
Decision Date 10/27/2022
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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