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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K031950
Device Name BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD
Applicant
Baylis Medical Co., Inc.
5160 Explorer Dr., Unit 33
Mississauga, Ontario,  CA L4W-4T7
Applicant Contact KRIS SHAH
Correspondent
Baylis Medical Co., Inc.
5160 Explorer Dr., Unit 33
Mississauga, Ontario,  CA L4W-4T7
Correspondent Contact KRIS SHAH
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/24/2003
Decision Date 07/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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