FDA 510(k) Application Details - K121340

Device Classification Name Device, Anti-Snoring

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510(K) Number K121340
Device Name Device, Anti-Snoring
Applicant SOMNOMED INC.
7460 Warren Pkwy Ste 190
Frisco, TX 75034 US
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Contact KATHRYN JAYNE
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 05/03/2012
Decision Date 05/30/2012
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 Y
Expedited Review



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