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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K231945
Device Name VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits
Applicant
AngioDynamics, Inc.
603 Queensbury
Queensbury,  NY  12804
Applicant Contact Laura Dwyer
Correspondent
AngioDynamics, Inc.
603 Queensbury
Queensbury,  NY  12804
Correspondent Contact Laura Dwyer
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
DYB  
Date Received06/30/2023
Decision Date 07/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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