510(k) K053082

BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 by Baylis Medical Co., Inc. — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2005
Date Received
November 2, 2005
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