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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K200120
Device Name LiteSaber Wire Torque Assist Device
Applicant
Vesatek, LLC
17171 Daimler St.
Irvine,  CA  92614
Applicant Contact David Look
Correspondent
Vesatek, LLC
17171 Daimler St.
Irvine,  CA  92614
Correspondent Contact Paul Gasser
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/21/2020
Decision Date 05/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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