The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Filter, Intravenous W/auto Air Vent.
| Device ID | K770589 |
| 510k Number | K770589 |
| Device Name: | FILTER, INTRAVENOUS W/AUTO AIR VENT |
| Classification | Set, Administration, Intravascular |
| Applicant | JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-03-28 |
| Decision Date | 1977-05-23 |