Stryker AIM Light Source And SafeLight Cable

Confocal Optical Imaging

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Aim Light Source And Safelight Cable.

Pre-market Notification Details

Device IDK173866
510k NumberK173866
Device Name:Stryker AIM Light Source And SafeLight Cable
ClassificationConfocal Optical Imaging
Applicant Stryker 5900 Optical Court San Jose,  CA  95138
ContactJay Nayar
CorrespondentJay Nayar
Stryker 5900 Optical Court San Jose,  CA  95138
Product CodeOWN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2017-12-20
Decision Date2018-01-18
Summary:summary

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