The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Jelco* Disc Filter-0.2 Micron.
| Device ID | K790471 |
| 510k Number | K790471 |
| Device Name: | JELCO* DISC FILTER-0.2 MICRON |
| Classification | Filter, Infusion Line |
| Applicant | JELCO LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-05 |
| Decision Date | 1979-04-30 |