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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, anti-snoring
510(k) Number K121285
Device Name ORAVAN OSA
Original Applicant
NEW JERSEY SNORING SOLUTIONS
769 northfield avenue
suite 154
west orange,  NJ  07052
Original Contact deborah stein
Regulation Number872.5570
Classification Product Code
LRK  
Date Received04/30/2012
Decision Date 03/08/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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