The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Air Vent Filter Needle, 0.45.
| Device ID | K771536 |
| 510k Number | K771536 |
| Device Name: | AIR VENT FILTER NEEDLE, 0.45 |
| Classification | Filter, Infusion Line |
| Applicant | JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-08-10 |
| Decision Date | 1977-10-25 |