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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 K193591
Device Name ARC 400
Applicant
Bowa-Electronics GmbH & Co. KG
Heinrich-Hertz-Strasse. 4-10
Gomaringen,  DE 72810
Applicant Contact Wolf-Ruediger Fritz
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Roxana Cernescu
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/23/2019
Decision Date 04/02/2020
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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