The following data is part of a premarket notification filed by Amisco Trading Corp. with the FDA for Delta-a.v. Fistula Cannulation Set.
| Device ID | K812621 |
| 510k Number | K812621 |
| Device Name: | DELTA-A.V. FISTULA CANNULATION SET |
| Classification | Needle, Fistula |
| Applicant | AMISCO TRADING 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 | 1981-09-15 |
| Decision Date | 1981-09-24 |