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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 K191234
Device Name APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets
Applicant
Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
Tuebingen,  DE 72072
Applicant Contact Henry Kutz
Correspondent
Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
Tuebingen,  DE 72072
Correspondent Contact Henry Kutz
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/08/2019
Decision Date 12/20/2019
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
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