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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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More FDA Info for this Product Code
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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