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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 K101372
Device Name DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
Applicant
Baylis Medical Co., Inc.
2645 Matheson Blvd. E.
Mississauga, Ontario,  CA L4W 5S4
Applicant Contact MEGHAL KHAKHAR
Correspondent
Baylis Medical Co., Inc.
2645 Matheson Blvd. E.
Mississauga, Ontario,  CA L4W 5S4
Correspondent Contact MEGHAL KHAKHAR
Regulation Number882.4725
Classification Product Code
GXI  
Date Received05/17/2010
Decision Date 08/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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