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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dilator, nasal
510(k) Number K120665
Device Name INVENT SNORING DEVICE
Original Applicant
VENTUS MEDICAL, INC.
1171 barroilhet drive
hillsborough,  CA  94010
Original Contact cindy domecus
Regulation Number874.3900
Classification Product Code
LWF  
Date Received03/05/2012
Decision Date 06/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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