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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Confocal Optical Imaging
510(k) Number K191046
Device Name L10 LED Light Source with AIM, L11 LED Light Source with AIM
Applicant
Stryker
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact Agatha Szeliga
Correspondent
Stryker
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact Agatha Szeliga
Regulation Number876.1500
Classification Product Code
OWN  
Subsequent Product Codes
FCS   FCW  
Date Received04/19/2019
Decision Date 05/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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