K944880 is an FDA 510(k) clearance for the BODILY FLUID DISPOSAL KIT. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Clinical Resources, Inc. (Elgin, US). The FDA issued a Cleared decision on December 15, 1994, 73 days after receiving the submission on October 3, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K944880 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 1994 |
| Decision Date | December 15, 1994 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX — Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |