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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 K101108
Device Name ERBE ESU MODEL VIO 100 C WITH ACCESSORIES
Applicant
Erbe USA, Inc.
2225 Northwest Pkwy.
Marietta,  GA  30067
Applicant Contact JOHN TARTAL
Correspondent
Erbe USA, Inc.
2225 Northwest Pkwy.
Marietta,  GA  30067
Correspondent Contact JOHN TARTAL
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/20/2010
Decision Date 07/16/2010
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
Predetermined Change
Control Plan Authorized		 No
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