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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 K181044
Device Name 400um Perforator and Accessory Vein Ablation Kit
Applicant
AngioDynamics, Inc.
26 Forest St.
Marlborough,  MA  01752
Applicant Contact Deepa R. Godhiya
Correspondent
AngioDynamics, Inc.
26 Forest St.
Marlborough,  MA  01752
Correspondent Contact Deepa R. Godhiya
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/19/2018
Decision Date 07/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02215369
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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