FDA 510(k) Application Details - K082849

Device Classification Name Device, Anti-Snoring

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510(K) Number K082849
Device Name Device, Anti-Snoring
Applicant CRANIOFACIAL PAIN CENTER OF IDAHO
8119 USTICK ROAD
BOISE, ID 83704 US
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Contact JAMISON R SPENCER
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 09/29/2008
Decision Date 07/16/2009
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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