The following data is part of a premarket notification filed by Lumendi, Llc with the FDA for Dilumen Endolumenal Interventional Platform.
Device ID | K182540 |
510k Number | K182540 |
Device Name: | DiLumen Endolumenal Interventional Platform |
Classification | Colonoscope And Accessories, Flexible/rigid |
Applicant | Lumendi, LLC 253 Post Road West Westport, CT 06880 |
Contact | Dennis Daniels |
Correspondent | John J. Smith Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004 |
Product Code | FDF |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-14 |
Decision Date | 2018-10-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10865309000239 | K182540 | 000 |
00865309000225 | K182540 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM 87255341 not registered Live/Pending |
Lumendi Ltd. 2016-12-02 |