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FDA 510(k) Application Details - K102329
Device Classification Name
Low Energy Direct Current Thermal Ablation System
More FDA Info for this Device
510(K) Number
K102329
Device Name
Low Energy Direct Current Thermal Ablation System
Applicant
ANGIODYNAMICS, INC.
155-A MOFFETT PARK DRIVE
SUITE 210
SUNNYVALE, CA 94089 US
Other 510(k) Applications for this Company
Contact
KIT CARIQUITAN
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
OAB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/17/2010
Decision Date
10/24/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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