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510(k) K121773

NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE by Biomerics — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2012
Date Received
June 18, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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