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510(k) K221452

Device
DiLumen C1, EZ1 and Tool Mount
Applicant
Lumendi, LLC
510(k) number
K221452
Product code
FDF
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-10
Date received
2022-05-18
Regulation
876.1500
Classification name
Colonoscope And Accessories, Flexible/Rigid
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dennis Daniels
Address
253 Post Rd. W. Westport CT US 06880 06880

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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