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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 K093511
Device Name SORING MBC200/BCC140
Applicant
Soring GmbH Medizintechnik
Justus-V. Liebig 2
Quickborn,  DE 25451
Applicant Contact JAN SCHUELLER-IWERSEN
Correspondent
Soring GmbH Medizintechnik
Justus-V. Liebig 2
Quickborn,  DE 25451
Correspondent Contact JAN SCHUELLER-IWERSEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/13/2009
Decision Date 04/16/2010
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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