The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Catheterization Tray & Kit.
| Device ID | K780259 |
| 510k Number | K780259 |
| Device Name: | CATHETERIZATION TRAY & KIT |
| Classification | Accessories, Catheter |
| Applicant | ARGON MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KGZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-15 |
| Decision Date | 1978-04-18 |