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FDA 510(k) Application Details - K183385
Device Classification Name
Low Energy Direct Current Thermal Ablation System
More FDA Info for this Device
510(K) Number
K183385
Device Name
Low Energy Direct Current Thermal Ablation System
Applicant
Angiodynamics
26 Forest Street
Marlborough, MA 01752 US
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Contact
Troy Roberts
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
OAB
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More FDA Info for this Product Code
Date Received
12/06/2018
Decision Date
06/18/2019
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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