Tablet Application

Endoscopic Central Control Unit

Smith & Nephew

The following data is part of a premarket notification filed by Smith & Nephew with the FDA for Tablet Application.

Pre-market Notification Details

Device IDK203566
510k NumberK203566
Device Name:Tablet Application
ClassificationEndoscopic Central Control Unit
Applicant Smith & Nephew 150 Minuteman Rd Andover,  MA  01810
ContactSean Reynolds
CorrespondentSean Reynolds
Smith & Nephew 150 Minuteman Rd Andover,  MA  01810
Product CodeODA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-07
Decision Date2021-05-13

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