FDA 510(k) Application Details - K133683

Device Classification Name Device, Anti-Snoring

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510(K) Number K133683
Device Name Device, Anti-Snoring
Applicant MICRODENTAL, INC.
5601 ARNOLD RD.
DUBLIN, CA 94568 US
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Contact LAURA SHEPPARD
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 12/02/2013
Decision Date 07/24/2014
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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