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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Catheter, Fiberoptic, Glass, Ureteral
510(k) Number K151243
Device Name STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
Applicant
Stryker Endoscopy
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact GOLNAZ MOEINI
Correspondent
Stryker Endoscopy
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact GOLNAZ MOEINI
Regulation Number876.4020
Classification Product Code
FCS  
Subsequent Product Code
FCW  
Date Received05/11/2015
Decision Date 08/20/2015
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
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