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510(k) K101372

DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 by Baylis Medical Co., Inc. — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2010
Date Received
May 17, 2010
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

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