510(k) K203064
K203064 is an FDA 510(k) premarket notification submitted by Plastikon Industries for the device "ICU Health Surgical Mask". The FDA issued a decision of Substantially Equivalent on Mar 23, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 23, 2021
- Date Received
- Oct 9, 2020
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
- 510(k)