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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 K061548
Device Name STRYKER URETERAL ILLUMINATION SYSTEM IV
Applicant
STRYKER CORP.
5900 Optical Court
San Jose,  CA  95138
Applicant Contact ERICA A WALTERS
Correspondent
STRYKER CORP.
5900 Optical Court
San Jose,  CA  95138
Correspondent Contact ERICA A WALTERS
Regulation Number876.4020
Classification Product Code
FCS  
Date Received06/05/2006
Decision Date 09/28/2006
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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