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510(k) K062937

TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU by Baylis Medical Co., Inc. — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2007
Date Received
September 28, 2006
Clearance Type
Traditional
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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