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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
Device Name STRYKER VIDEO URETEROSCOPE
Original Applicant
Stryker Endoscopy
5900 optical ct.
san jose,  CA  95138
Original Contact kevin potgieter, rac
Regulation Number876.1500
Classification Product Code
FGB  
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
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