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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 K915296
Device Name MONOPOLAR ELECTRODE
Applicant
Lifeguard Medical Products, Inc.
400 Lathrop Ave.
Suite 200
River Forest,  IL  60305
Applicant Contact DOURGLAS HULFISH
Correspondent
Lifeguard Medical Products, Inc.
400 Lathrop Ave.
Suite 200
River Forest,  IL  60305
Correspondent Contact DOURGLAS HULFISH
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/15/1991
Decision Date 09/03/1992
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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