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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 K131369
Device Name FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVENUE
EL SEGUNDO,  CA  90245
Applicant Contact LEIGH SPOTTEN
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVENUE
EL SEGUNDO,  CA  90245
Correspondent Contact LEIGH SPOTTEN
Regulation Number876.1500
Classification Product Code
FGB  
Date Received05/13/2013
Decision Date 11/26/2013
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
Recalls CDRH Recalls
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