DiLumen Endolumenal Interventional Platform (DiLumen)

Colonoscope And Accessories, Flexible/rigid

Lumendi, LLC

The following data is part of a premarket notification filed by Lumendi, Llc with the FDA for Dilumen Endolumenal Interventional Platform (dilumen).

Pre-market Notification Details

Device IDK210851
510k NumberK210851
Device Name:DiLumen Endolumenal Interventional Platform (DiLumen)
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant Lumendi, LLC 253 Post Road West Westport,  CT  06880
ContactDennis Daniels
CorrespondentJohn J. Smith
Hogan Lovells U.S. LLP 555 13th Street NW Washington,  DC  20004
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-22
Decision Date2021-04-21

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