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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 K142614
Device Name AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch Procedure Kits
Applicant
AngioDynamics, Inc.
603 Queensbury Avenue
Queensbury,  NY  12804
Applicant Contact Teri Juckett
Correspondent
AngioDynamics, Inc.
603 Queensbury Avenue
Queensbury,  NY  12804
Correspondent Contact Teri Juckett
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/16/2014
Decision Date 10/10/2014
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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