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 |