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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 K071745
Device Name BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
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 Received06/27/2007
Decision Date 07/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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