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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 K002565
Device Name BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)
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 Number882.4400
Classification Product Code
GXD  
Date Received08/17/2000
Decision Date 05/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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