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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 K062712
Device Name ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094
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 Received09/11/2006
Decision Date 01/26/2007
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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