FDA 510(k) Application Details - K130067

Device Classification Name Device, Anti-Snoring

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510(K) Number K130067
Device Name Device, Anti-Snoring
Applicant BIOMODELING SOLUTIONS, LLS
15455 NW GREENBRIER PARKWAY
BEAVERTON, OR 97006 US
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Contact COLETTE COZEAN, PH.D.
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 01/10/2013
Decision Date 05/08/2014
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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