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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 K171921
Device Name VenaCure EVLT NeverTouch Procedure Kit
Applicant
AngioDynamics, Inc.
26 Forest Street
Marlborough,  MA  01752
Applicant Contact Hans Kjolhede
Correspondent
AngioDynamics, Inc.
26 Forest Street
Marlborough,  MA  01752
Correspondent Contact Hans Kjolhede
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/27/2017
Decision Date 08/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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