FDA 510(k) Application Details - K041184

Device Classification Name Device, Anti-Snoring

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510(K) Number K041184
Device Name Device, Anti-Snoring
Applicant NTI-TSS, INC.
5327 LA GLORIETA PO BX 2145
RANCHO SANTA FE, CA 92067-2145 US
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Contact JAMES BOYD
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 05/06/2004
Decision Date 05/03/2005
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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