The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Needles, Design Change, Iv Catheters.
| Device ID | K780896 |
| 510k Number | K780896 |
| Device Name: | NEEDLES, DESIGN CHANGE, IV CATHETERS |
| Classification | Needle, Catheter |
| Applicant | JELCO LABORATORIES KS |
| Product Code | GCB |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-05-30 |
| Decision Date | 1978-08-23 |