FDA 510(k) Application Details - K173064

Device Classification Name Device, Anti-Snoring

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510(K) Number K173064
Device Name Device, Anti-Snoring
Applicant B. Fareid, DDS, PC
1591 Earl Street
Kingsburg, CA 93631 US
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Contact Behzad Fareid
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 09/29/2017
Decision Date 03/08/2019
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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