FDA 510(k) Application Details - K171576

Device Classification Name Device, Anti-Snoring

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510(K) Number K171576
Device Name Device, Anti-Snoring
Applicant Panthera Dental Inc.
2035, rue du Haut-Bord
Quebec city G1N 4N7 CA
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Contact Martine Fortin
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 05/30/2017
Decision Date 02/22/2018
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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