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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 K883189
Device Name MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
10111 W. JEFFERSON BLVD.
CULVER CITY,  CA  90232 -3578
Applicant Contact ROBERT GIORGINI
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
10111 W. JEFFERSON BLVD.
CULVER CITY,  CA  90232 -3578
Correspondent Contact ROBERT GIORGINI
Regulation Number876.4480
Classification Product Code
FFK  
Date Received07/28/1988
Decision Date 02/13/1989
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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