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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Electro-Hydraulic
510(k) Number K230488
Device Name EL27-Compact; Sterile EHL-Probes
Applicant
Walz Elektronik GmbH
Walddorfer Strasse 40
Rohrdorf,  DE 72229
Applicant Contact Bernd Vollmer
Correspondent
Walz Elektronik GmbH
Walddorfer Strasse 40
Rohrdorf,  DE 72229
Correspondent Contact Bernd Vollmer
Regulation Number876.4480
Classification Product Code
FFK  
Date Received02/23/2023
Decision Date 08/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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