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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 K023733
Device Name COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR
Applicant
Ingenjorsfirman Bjorn Bergdahl AB
Hallesas 6452
Billdal,  SE SE 427 51
Applicant Contact BJORN BERGDAHL
Correspondent
Ingenjorsfirman Bjorn Bergdahl AB
Hallesas 6452
Billdal,  SE SE 427 51
Correspondent Contact BJORN BERGDAHL
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/06/2002
Decision Date 05/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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