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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 K024047
Device Name ERBE VIO APC WITH ACCESSORIES
Applicant
Erbe USA, Inc.
550 Belgrave Ln.
Tucker,  GA  30084
Applicant Contact JULIE STEPHENS
Correspondent
Erbe USA, Inc.
550 Belgrave Ln.
Tucker,  GA  30084
Correspondent Contact JULIE STEPHENS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/09/2002
Decision Date 01/08/2003
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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