FDA 510(k) Application Details - K182202

Device Classification Name Device, Anti-Snoring

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510(K) Number K182202
Device Name Device, Anti-Snoring
Applicant Comfort Acrylics, Inc.
2103 NE 272nd Ave.
Camas, WA 98607 US
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Contact Richard W. Moore
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 08/14/2018
Decision Date 01/11/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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