FDA 510(k) Application Details - K050592

Device Classification Name Device, Anti-Snoring

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510(K) Number K050592
Device Name Device, Anti-Snoring
Applicant SOMNOMED LTD
PO BOX 560
STILLWATER, MN 55082 US
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Contact ELAINE DUNCAN
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 03/08/2005
Decision Date 07/12/2005
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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