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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 K152159
Device Name Oravan Herbst
Applicant
Oravanosa, LLC
769 Northfield Ave., Suite 160
West Orange,  NJ  07052
Applicant Contact Deborah Stein
Correspondent
Oravanosa, LLC
769 Northfield Ave., Suite 160
West Orange,  NJ  07052
Correspondent Contact Deborah Stein
Regulation Number872.5570
Classification Product Code
LRK  
Date Received08/03/2015
Decision Date 10/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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