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FDA 510(k) Application Details - K140663
Device Classification Name
Device, Anti-Snoring
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510(K) Number
K140663
Device Name
Device, Anti-Snoring
Applicant
DISTAR, LLC
201 THIRD STREET NW, SUITE 1340
ALBUQUERQUE, NM 87102 US
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Contact
JANEEN VILVEN-DOGGETT
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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
03/18/2014
Decision Date
12/12/2014
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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