The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Catheter Metal Hub/radiopaque.
| Device ID | K790967 |
| 510k Number | K790967 |
| Device Name: | CATHETER METAL HUB/RADIOPAQUE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-22 |
| Decision Date | 1979-06-27 |