FDA 510(k) Application Details - K170053

Device Classification Name Device, Anti-Snoring

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510(K) Number K170053
Device Name Device, Anti-Snoring
Applicant The Center for Craniofacial & Dental Sleep Medicine
4545 Sweetwater Blvd
Sugarland, TX 77479 US
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Contact Samuel Cress
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 01/05/2017
Decision Date 11/28/2017
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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