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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 K905553
Device Name LITHOTRIPTOR SYSTEM MODEL 27080
Applicant
Karl Storz GmbH & Co. (Kst)
10111 W. Jefferson Blvd.
Culver City,  CA  90232
Applicant Contact ROBERT R GIORGINI
Correspondent
Karl Storz GmbH & Co. (Kst)
10111 W. Jefferson Blvd.
Culver City,  CA  90232
Correspondent Contact ROBERT R GIORGINI
Regulation Number876.4480
Classification Product Code
FFK  
Date Received12/11/1990
Decision Date 06/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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