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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Fiberoptic, Routine
510(k) Number K082813
Device Name STRYKER LED LIGHTSOURCE
Applicant
Stryker Corp.
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact DESIREE CRISOLO
Correspondent
Stryker Corp.
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact DESIREE CRISOLO
Regulation Number876.1500
Classification Product Code
FCW  
Date Received09/24/2008
Decision Date 12/19/2008
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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