510(k) K190305
K190305 is an FDA 510(k) premarket notification submitted by International Medical Industries, Inc. for the device "Additive Cap". The FDA issued a decision of Substantially Equivalent on April 30, 2019. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. International Medical Industries, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2019
- Date Received
- February 12, 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