FDA 510(k) Application Details - K140663

Device Classification Name Device, Anti-Snoring

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510(K) Number K140663
Device Name Device, Anti-Snoring
Applicant DISTAR, LLC
201 THIRD STREET NW, SUITE 1340
ALBUQUERQUE, NM 87102 US
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Contact JANEEN VILVEN-DOGGETT
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 03/18/2014
Decision Date 12/12/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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