FDA 510(k) Application Details - K121761

Device Classification Name Device, Anti-Snoring

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510(K) Number K121761
Device Name Device, Anti-Snoring
Applicant TOMED DR. TOUSSAINT GMBH
854 US ROUTE 3
HOLDERNESS, NH 03245 US
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Contact SCOTT WHITCOMB
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 06/15/2012
Decision Date 09/28/2012
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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