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 |