Connected OR Hub With Device And Voice Control

Laparoscope, General & Plastic Surgery

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Connected Or Hub With Device And Voice Control.

Pre-market Notification Details

Device IDK212055
510k NumberK212055
Device Name:Connected OR Hub With Device And Voice Control
ClassificationLaparoscope, General & Plastic Surgery
Applicant Stryker Corporation 5900 Optical Ct San Jose,  CA  95138
ContactEugene Perelshteyn
CorrespondentEugene Perelshteyn
Stryker Corporation 5900 Optical Ct San Jose,  CA  95138
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-01
Decision Date2021-12-16

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