The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Medisystems Fistula Needles.
| Device ID | K823068 |
| 510k Number | K823068 |
| Device Name: | MEDISYSTEMS FISTULA NEEDLES |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | MEDISYSTEMS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-19 |
| Decision Date | 1983-01-26 |