The following data is part of a premarket notification filed by Medron, Llc with the FDA for Medron Vessel Dilator - 6f X 22cm Hdpe Dilator, Medron Vessel Dilator - 15.5f - 17.5f Hdpe Dilator.
| Device ID | K192283 |
| 510k Number | K192283 |
| Device Name: | MEDRON Vessel Dilator - 6F X 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | Medron, LLC 1518 S Gladiola Street Salt Lake City, UT 84104 |
| Contact | David Kujawa |
| Correspondent | David Kujawa Medron, LLC 1518 S Gladiola Street Salt Lake City, UT 84104 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-22 |
| Decision Date | 2020-05-06 |