The following data is part of a premarket notification filed by Omnimedical with the FDA for Calculi Filter Cup.
| Device ID | K820180 |
| 510k Number | K820180 |
| Device Name: | CALCULI FILTER CUP |
| Classification | Container, Specimen, Sterile |
| Applicant | OMNIMEDICAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMH |
| CFR Regulation Number | 864.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-22 |
| Decision Date | 1982-02-05 |