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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K231023
Device Name ERBEJET® 2 System
Applicant
Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
Tuebingen,  DE 72072
Applicant Contact Matthias Kollek
Correspondent
Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
Tuebingen,  DE 72072
Correspondent Contact Matthias Kollek
Regulation Number880.5475
Classification Product Code
FQH  
Subsequent Product Code
GEI  
Date Received04/11/2023
Decision Date 06/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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