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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 K895737
Device Name THE DOCTOR'S CHOICE ELECTRODE
Applicant
The Skin Care Centre
2 Jane St.
Suite 207, Toronto
Ontario, Canada,  CA M6S 4W3
Applicant Contact SAKSUN, M.D.
Correspondent
The Skin Care Centre
2 Jane St.
Suite 207, Toronto
Ontario, Canada,  CA M6S 4W3
Correspondent Contact SAKSUN, M.D.
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/26/1989
Decision Date 11/08/1989
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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