FDA 510(k) Application Details - K103076

Device Classification Name Device, Anti-Snoring

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510(K) Number K103076
Device Name Device, Anti-Snoring
Applicant DYNAFLEX
611 WEST 5TH STREET
THIRD FLOOR
AUSTIN, TX 78701 US
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Contact STUART R GOLDMAN
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 10/18/2010
Decision Date 02/23/2011
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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