L10 LED Light Source With AIM, L11 LED Light Source With AIM, AIM SafeLight Cable

Confocal Optical Imaging

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for L10 Led Light Source With Aim, L11 Led Light Source With Aim, Aim Safelight Cable.

Pre-market Notification Details

Device IDK192292
510k NumberK192292
Device Name:L10 LED Light Source With AIM, L11 LED Light Source With AIM, AIM SafeLight Cable
ClassificationConfocal Optical Imaging
Applicant Stryker 5900 Optical Court San Jose,  CA  95138
ContactApril Malmborg
CorrespondentApril Malmborg
Stryker 5900 Optical Court San Jose,  CA  95138
Product CodeOWN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-23
Decision Date2019-11-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327462777 K192292 000
07613327462760 K192292 000

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