ControlRad Sterile Cover

Drape, Surgical

ControlRad, Inc

The following data is part of a premarket notification filed by Controlrad, Inc with the FDA for Controlrad Sterile Cover.

Pre-market Notification Details

Device IDK200238
510k NumberK200238
Device Name:ControlRad Sterile Cover
ClassificationDrape, Surgical
Applicant ControlRad, Inc 275 Scientific Drive NW #1100 Norcross,  GA  30092
ContactChris Fair
CorrespondentLinda Braddon
Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock,  GA  30188
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-31
Decision Date2020-04-26

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