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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 K851304
Device Name NON/GEL ADHESIVE DISPERSIVE ELECTRODE 3427,33-4270
Applicant
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact JIM LENICK
Correspondent
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact JIM LENICK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/01/1985
Decision Date 09/06/1985
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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