The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Medisystems Hemodialysis Fistula Set.
| Device ID | K910734 |
| 510k Number | K910734 |
| Device Name: | MEDISYSTEMS HEMODIALYSIS FISTULA SET |
| Classification | Needle, Fistula |
| Applicant | MEDISYSTEMS CORP. 21ST FLOOR 345 CALIFORNIA STREET San Francisco, CA 94104 |
| Contact | Alan C Hinton |
| Correspondent | Alan C Hinton MEDISYSTEMS CORP. 21ST FLOOR 345 CALIFORNIA STREET San Francisco, CA 94104 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-21 |
| Decision Date | 1991-06-20 |