The following data is part of a premarket notification filed by Dimesol, Inc. with the FDA for Dimesol Disposable Av Fistula Needle Set (non-safety Series) And Dimesol Disposable Av Fistula Needle Set (safety Series).
| Device ID | K171505 |
| 510k Number | K171505 |
| Device Name: | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) And Dimesol Disposable AV Fistula Needle Set (Safety Series) |
| Classification | Needle, Fistula |
| 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 | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-23 |
| Decision Date | 2018-05-17 |
| Summary: | summary |