510(k) K210818
K210818 is an FDA 510(k) premarket notification submitted by Us Infusion Inc. D/B/A Truecare Biomedix-USA for the device "TrueCare Biomedix Tamper Evident Cap". The FDA issued a decision of Substantially Equivalent on Sep 15, 2021. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 15, 2021
- Date Received
- Mar 18, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)