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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 DRIVE, UNIT 5
MISSISSAUGA,  CA L4W-4T7
Applicant Contact KRIS SHAH
Correspondent
BAYLIS MEDICAL CO., INC.
5160 EXPLORER DRIVE, 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
Recalls CDRH Recalls
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