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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 K073498
Device Name LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY RUDOLF SYSTEM
Applicant
Rudolf Medical GmbH + Co. KG
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Applicant Contact FRANZ MENEAN
Correspondent
Rudolf Medical GmbH + Co. KG
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Correspondent Contact FRANZ MENEAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/13/2007
Decision Date 09/19/2008
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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