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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, ultrasonic surgical
510(k) Number K192963
Device Name Kogent Torus Ultrasonic Aspirator
Applicant
Katalyst Surgical, LLC
754 Goddard Avenue
Chesterfield,  MO  63005
Applicant Contact Meryl Koch Wilhelm
Correspondent
Katalyst Surgical, LLC
754 Goddard Avenue
Chesterfield,  MO  63005
Correspondent Contact Meryl Koch Wilhelm
Classification Product Code
LFL  
Date Received10/23/2019
Decision Date 06/19/2020
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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