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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 K953992
Device Name LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE
Applicant
Lmi Lightwave Medical Industries , Ltd.
2660 Oak St.
Vancouver,  CA V6H 3Z6
Applicant Contact MARTIN POULIN
Correspondent
Lmi Lightwave Medical Industries , Ltd.
2660 Oak St.
Vancouver,  CA V6H 3Z6
Correspondent Contact MARTIN POULIN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/24/1995
Decision Date 10/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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