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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 K060232
Device Name TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES
Applicant
TROKAMED GMBH
KLEINE BREITE 17
GEISINGEN,  DE 78187
Applicant Contact KARLHEINZ TRONDLE
Correspondent
TROKAMED GMBH
KLEINE BREITE 17
GEISINGEN,  DE 78187
Correspondent Contact KARLHEINZ TRONDLE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/30/2006
Decision Date 07/12/2006
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
Recalls CDRH Recalls
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