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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 K143306
FOIA Releasable 510(k) K143306
Device Name ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
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  
Subsequent Product Code
FQH  
Date Received11/18/2014
Decision Date 10/27/2015
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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