EverLift Submucosal Lifting Agent

Submucosal Injection Agent

GI Supply

The following data is part of a premarket notification filed by Gi Supply with the FDA for Everlift Submucosal Lifting Agent.

Pre-market Notification Details

Device IDK191923
510k NumberK191923
Device Name:EverLift Submucosal Lifting Agent
ClassificationSubmucosal Injection Agent
Applicant GI Supply 5069 Ritter Road, Suite 104 Mechanicsburg,  PA  17055
ContactErika Parry
CorrespondentErika Parry
GI Supply 5069 Ritter Road, Suite 104 Mechanicsburg,  PA  17055
Product CodePLL  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-18
Decision Date2020-06-20

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