The following data is part of a premarket notification filed by Dimesol, Inc. with the FDA for Dimesol Tubing Sets For Hemodialysis.
| Device ID | K171952 |
| 510k Number | K171952 |
| Device Name: | Dimesol Tubing Sets For Hemodialysis |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | Dimesol, Inc. 509 Fishing Creek Road Lewisberry, PA 17339 |
| Contact | Stephen P. Callaghan |
| Correspondent | Courtney J. Miller Frost Brown Todd LLC 10 West Broad Street, Suite 2300 Columbus, OH 43215 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-29 |
| Decision Date | 2018-03-30 |
| Summary: | summary |