510(k) K221409
K221409 is an FDA 510(k) premarket notification submitted by Paneffort, LLC for the device "Paneffort 3-ply Surgical and Procedural Masks". The FDA issued a decision of Substantially Equivalent on July 25, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Paneffort, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2022
- Date Received
- May 16, 2022
- 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