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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K191990
Device Name OSW Aligner System
Applicant
Osw Manufacturing, LLC
35778 Elk Ln.
Murrieta,  CA  92563
Applicant Contact Ian Kitching
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number872.5470
Classification Product Code
NXC  
Date Received07/25/2019
Decision Date 08/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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