780 Nm 1688 4K Camera System, 780 Nm L11 LED Light Source With AIM And Safelight Cable

Laparoscope, General & Plastic Surgery

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for 780 Nm 1688 4k Camera System, 780 Nm L11 Led Light Source With Aim And Safelight Cable.

Pre-market Notification Details

Device IDK214046
510k NumberK214046
Device Name:780 Nm 1688 4K Camera System, 780 Nm L11 LED Light Source With AIM And Safelight Cable
ClassificationLaparoscope, General & Plastic Surgery
Applicant Stryker 5900 Optical Court San Jose,  CA  95138
ContactMichelle Hughes
CorrespondentMichelle Hughes
Stryker 5900 Optical Court San Jose,  CA  95138
Product CodeGCJ  
Subsequent Product CodeFCS
Subsequent Product CodeFCW
Subsequent Product CodeGWG
Subsequent Product CodeOWN
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-12-27
Decision Date2022-05-25

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