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510(k) K183177

Nitinol Thermocouple (TCN) Electrode by Boston Scientific Corporation — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2019
Date Received
November 16, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Radiofrequency Lesion
Device Class
Class II
Regulation Number
882.4725
Review Panel
NE
Submission Type

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