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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 K173866
Device Name Stryker AIM Light Source and SafeLight cable
Applicant
Stryker
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact Jay Nayar
Correspondent
Stryker
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact Jay Nayar
Regulation Number876.1500
Classification Product Code
OWN  
Date Received12/20/2017
Decision Date 01/18/2018
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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