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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 K023924
Device Name AUTOCON II 200 ELECTROSURGICAL GENERATOR
Applicant
Karl Storz Endoscopy
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact JAMES A LEE
Correspondent
Karl Storz Endoscopy
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact JAMES A LEE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/25/2002
Decision Date 02/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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