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510(k) K190256

Rulo Radiofrequency Lesion Probe by Epimed International, Inc. — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2019
Date Received
February 7, 2019
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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