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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 K121112
Original Applicant
Stryker Endoscopy
5900 optical ct.
san jose,  CA  95138
Original Contact kevin potgieter, rac
Regulation Number876.1500
Classification Product Code
Date Received04/12/2012
Decision Date 09/12/2012
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