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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 K190236
Device Name O2Vent Optima
Applicant
Oventus Manufacturing Pty, Ltd.
1 Swann Rd.
Indooroopilly,  AU 4068
Applicant Contact Robyn Woidtke
Correspondent
Regulatory and Clinical Research Institute
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Correspondent Contact M.W. (Andy) Anderson
Regulation Number872.5570
Classification Product Code
LRK  
Date Received02/06/2019
Decision Date 08/29/2019
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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