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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 K053282
Device Name ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP
Applicant
PAJUNK GMBH
KARL-HALL-STRASSE 1
GEISINGEN,  DE D-78187
Applicant Contact CHRISTIAN QUASS
Correspondent
PAJUNK GMBH
KARL-HALL-STRASSE 1
GEISINGEN,  DE D-78187
Correspondent Contact CHRISTIAN QUASS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/25/2005
Decision Date 12/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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