The following data is part of a premarket notification filed by Health Care Technologies with the FDA for Hct Empty Eva Container Pack.
| Device ID | K190328 |
| 510k Number | K190328 |
| Device Name: | HCT Empty EVA Container Pack |
| Classification | Container, I.v. |
| Applicant | Health Care Technologies 200 Butterfield Drive Ashland, MA 01721 |
| Contact | Adam T. Benson |
| Correspondent | Dawn Norman MRC X, LLC 6075 Poplar Avenue, Suite 500 Memphis, TN 38112 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-13 |
| Decision Date | 2019-08-15 |