The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Jelco & Kvo Catheter Placement Unit.
| Device ID | K791372 |
| 510k Number | K791372 |
| Device Name: | JELCO & KVO CATHETER PLACEMENT UNIT |
| Classification | Catheter, Infusion |
| Applicant | JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JCY |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-24 |
| Decision Date | 1979-09-12 |