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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 K072478
Device Name BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD
Applicant
Baylis Medical Co., Inc.
2645 Matheson Blvd. E.
Mississauga, Ontario,  CA L4W 5S4
Applicant Contact MEGHAL KHAKHAR
Correspondent
Baylis Medical Co., Inc.
2645 Matheson Blvd. E.
Mississauga, Ontario,  CA L4W 5S4
Correspondent Contact MEGHAL KHAKHAR
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
GXD  
Date Received09/04/2007
Decision Date 12/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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