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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystourethroscope
510(k) Number K131364
Device Name FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
Applicant
Karl Storz Endoscopy-America, Inc.
2151 E Grand Ave.
El Segundo,  CA  90245 -5017
Applicant Contact SHIVEN GANDHI
Correspondent
Karl Storz Endoscopy-America, Inc.
2151 E Grand Ave.
El Segundo,  CA  90245 -5017
Correspondent Contact SHIVEN GANDHI
Regulation Number876.1500
Classification Product Code
FBO  
Date Received05/13/2013
Decision Date 01/02/2014
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
Recalls CDRH Recalls
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