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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 K002389
Device Name BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
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 Received08/04/2000
Decision Date 10/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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