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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K062937
Device Name TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
Applicant
Baylis Medical Co., Inc.
2580 Matheson Blvd. E
Mississauga, Ontario,  CA L4W 4J1
Applicant Contact MEGHAL KHAKHAR
Correspondent
Baylis Medical Co., Inc.
2580 Matheson Blvd. E
Mississauga, Ontario,  CA L4W 4J1
Correspondent Contact MEGHAL KHAKHAR
Regulation Number882.4725
Classification Product Code
GXI  
Date Received09/28/2006
Decision Date 01/08/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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