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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 K023966
Device Name DISPOSABLE BI-POLAR CABLE
Applicant
Modern Medical Equipment Mfg., Ltd.
1705 Dabney Rd.
Richmond,  VA  23230
Applicant Contact ROGER STRUBE
Correspondent
Modern Medical Equipment Mfg., Ltd.
1705 Dabney Rd.
Richmond,  VA  23230
Correspondent Contact ROGER STRUBE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/29/2002
Decision Date 02/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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