FDA 510(k) Application Details - K121285

Device Classification Name Device, Anti-Snoring

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510(K) Number K121285
Device Name Device, Anti-Snoring
Applicant NEW JERSEY SNORING SOLUTIONS
769 NORTHFIELD AVENUE
SUITE 154
WEST ORANGE, NJ 07052 US
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Contact DEBORAH STEIN
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 04/30/2012
Decision Date 03/08/2013
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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