The following data is part of a premarket notification filed by Lumenr, Llc with the FDA for Lumenr Tissue Retractor System.
| Device ID | K153698 |
| 510k Number | K153698 |
| Device Name: | LumenR Tissue Retractor System |
| Classification | Endoscopic Contamination Prevention Sheath |
| Applicant | LumenR, LLC 253 MAIN STREET, SUITE 270 Matawan, NJ 07747 |
| Contact | Gregory Piskun |
| Correspondent | Joseph Azary JOSEPH AZARY 543 LONG HILL AVENUE Shelton, CT 06484 |
| Product Code | ODB |
| Subsequent Product Code | FED |
| Subsequent Product Code | GAD |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-23 |
| Decision Date | 2016-04-19 |
| Summary: | summary |