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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 K982542
Device Name STRYKER URETERAL ILLUMINATOR SYSTEM III
Applicant
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051
Applicant Contact TONY LEE
Correspondent
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051
Correspondent Contact TONY LEE
Regulation Number876.4020
Classification Product Code
FCS  
Date Received07/21/1998
Decision Date 09/22/1998
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
Recalls CDRH Recalls
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