SDC3 HD Information Management System With Wireless Device Control Capability

Laparoscope, General & Plastic Surgery

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Sdc3 Hd Information Management System With Wireless Device Control Capability.

Pre-market Notification Details

Device IDK210584
510k NumberK210584
Device Name:SDC3 HD Information Management System With Wireless Device Control Capability
ClassificationLaparoscope, General & Plastic Surgery
Applicant Stryker 5900 Optical Ct San Jose,  CA  95138
ContactDivya Sekar
CorrespondentDivya Sekar
Stryker 5900 Optical Ct San Jose,  CA  95138
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-26
Decision Date2021-03-18

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