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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name generator, lesion, radiofrequency
510(k) Number K181864
Device Name Polaris RF Ablation System
Applicant
Baylis Medical Company Inc.
2775 Matheson Blvd. East
mississauga,  CA l4w 4p7
Applicant Contact may tsai
Correspondent
Baylis Medical Company Inc.
2775 Matheson Blvd. East
mississauga,  CA l4w 4p7
Correspondent Contact may tsai
Regulation Number882.4400
Classification Product Code
GXD  
Subsequent Product Code
GXI  
Date Received07/12/2018
Decision Date 01/02/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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