FDA 510(k) Application Details - K061688

Device Classification Name Device, Anti-Snoring

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510(K) Number K061688
Device Name Device, Anti-Snoring
Applicant TOMED DR. TOUSSAINT GMBH
LINDBERGHSTR. 3A
BENSHEIM D-64625 DE
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Contact WINFRIED TOUSSAINT
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 06/15/2006
Decision Date 09/08/2006
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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