K820180 is an FDA 510(k) clearance for the CALCULI FILTER CUP. This device is classified as a Container, Specimen, Sterile (Class I - General Controls, product code FMH).
Submitted by Omnimedical (Mchenry, US). The FDA issued a Cleared decision on February 5, 1982, 14 days after receiving the submission on January 22, 1982.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 864.3250.
| 510(k) Number | K820180 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1982 |
| Decision Date | February 05, 1982 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMH — Container, Specimen, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3250 |