DiLumen Endolumenal Interventional Platform
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.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10865309000239 | K182540 | 000 |
| 00865309000225 | K182540 | 000 |
Trademark Results [DiLumen Endolumenal Interventional Platform]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM 87255341 not registered Live/Pending |
Lumendi Ltd. 2016-12-02 |
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