FDA 510(k) Application Details - K100185

Device Classification Name Device, Anti-Snoring

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510(K) Number K100185
Device Name Device, Anti-Snoring
Applicant SLEEP MEDICINE NETWORK, INC.
7931 NE HALSEY SUITE 305
PORTLAND, OR 97213 US
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Contact RICHARD MOORE
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 01/22/2010
Decision Date 11/19/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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