FDA 510(k) Application Details - K073004

Device Classification Name Device, Anti-Snoring

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510(K) Number K073004
Device Name Device, Anti-Snoring
Applicant SOMNOMED INC.
3537 TEASLEY LANE
DENTON, TX 76210 US
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Contact ASHLEY TRUITT
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 10/24/2007
Decision Date 01/30/2008
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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