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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthopedic manual surgical instrument
510(k) Number K192873
Device Name SX-One MicroKnife
Applicant
Sonex Health, Inc.
11 1st Ave SW
Rochester,  MN  55902
Applicant Contact Aaron Keenan
Correspondent
Keri Ng Consulting
11 1st Ave SW
Rochester,  MN  55902
Correspondent Contact Keri Ng
Regulation Number888.4540
Classification Product Code
LXH  
Date Received10/08/2019
Decision Date 12/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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