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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ureteroscope and accessories, flexible/rigid
510(k) Number K925128
Device Name THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
10111 W. JEFFERSON BLVD.
CULVER CITY,  CA  90232 -3578
Applicant Contact ROBERT R GIORGINI
Correspondent
Karl Storz Endoscopy- America, Inc.
2151 East Grand Ave.
El Segundo,  CA  90245 -5017
Correspondent Contact Leigh R Spotten
Regulation Number876.1500
Classification Product Code
FGB  
Date Received10/13/1992
Decision Date 08/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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