The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Medisystems Fistula Needle.
| Device ID | K811838 |
| 510k Number | K811838 |
| Device Name: | MEDISYSTEMS FISTULA NEEDLE |
| Classification | Needle, Fistula |
| Applicant | MEDISYSTEMS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-09-08 |