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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Energy Direct Current Thermal Ablation System
510(k) Number K150089
Device Name NanoKnife System
Applicant
ANGIODYNAMICS, INC.
26 FOREST STREET
MARLBOROUGH,  MA  01752
Applicant Contact Suzanne Goodman
Correspondent
ANGIODYNAMICS, INC.
26 FOREST STREET
MARLBOROUGH,  MA  01752
Correspondent Contact Suzanne Goodman
Regulation Number878.4400
Classification Product Code
OAB  
Date Received01/16/2015
Decision Date 06/18/2015
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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