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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 K192292
Device Name L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable
Applicant
Stryker
5900 Optical Court
San Jose,  CA  95138
Applicant Contact April Malmborg
Correspondent
Stryker
5900 Optical Court
San Jose,  CA  95138
Correspondent Contact April Malmborg
Regulation Number876.1500
Classification Product Code
OWN  
Subsequent Product Code
GCJ  
Date Received08/23/2019
Decision Date 11/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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