510(k) K190328
K190328 is an FDA 510(k) premarket notification submitted by Health Care Technologies for the device "HCT Empty EVA Container Pack". The FDA issued a decision of Substantially Equivalent on August 15, 2019. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2019
- Date Received
- February 13, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, I.V.
- Device Class
- Class II
- Regulation Number
- 880.5025
- Review Panel
- HO
- Submission Type