510(k) K212302
K212302 is an FDA 510(k) premarket notification submitted by Baylab USA, LLC for the device "BAYLAB 3-Ply Surgical Mask (BEACON I)". The FDA issued a decision of Substantially Equivalent on Dec 7, 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
- Dec 7, 2021
- Date Received
- Jul 23, 2021
- Clearance Type
- Traditional
- 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)