K190328 is an FDA 510(k) clearance for the HCT Empty EVA Container Pack. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Health Care Technologies (Ashland, US). The FDA issued a Cleared decision on August 15, 2019, 183 days after receiving the submission on February 13, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K190328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2019 |
| Decision Date | August 15, 2019 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KPE - Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |