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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K191357
Device Name Flexible HD Cysto-Urethroscope System
Applicant
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
El Segundo,  CA  90245
Applicant Contact Irina Fedorov
Correspondent
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
El Segundo,  CA  90245
Correspondent Contact Irina Fedorov
Regulation Number876.1500
Classification Product Code
FAJ  
Subsequent Product Code
FBO  
Date Received05/21/2019
Decision Date 09/18/2019
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
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