FDA 510(k) Application Details - K222127

Device Classification Name Device, Anti-Snoring

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510(K) Number K222127
Device Name Device, Anti-Snoring
Applicant The TMJ Clinic, PC.
833 SW 11th Ave. # 810
Portland, OR 97205 US
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Contact John Summer
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 07/18/2022
Decision Date 10/24/2022
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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