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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 K972846
Device Name BMC RF CANNULA
Applicant
Baylis Medical Co., Inc.
5160 Explorer Dr., Unit 5
Mississauga,  CA L4W-4T7
Applicant Contact KRIS SHAH
Correspondent
Baylis Medical Co., Inc.
5160 Explorer Dr., Unit 5
Mississauga,  CA L4W-4T7
Correspondent Contact KRIS SHAH
Regulation Number882.4725
Classification Product Code
GXI  
Date Received08/01/1997
Decision Date 07/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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