FDA 510(k) Application Details - K143244

Device Classification Name Device, Anti-Snoring

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510(K) Number K143244
Device Name Device, Anti-Snoring
Applicant Panthera Dental Inc.
2035 rue de Haut-Bord
Quebec G1n 4R7 CA
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Contact Guy Bernard Bantsiele
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 11/12/2014
Decision Date 12/15/2014
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 Y
Expedited Review



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