Clearance Summary
MAF Guard received FDA 510(k) clearance under submission number K211487, sponsored by Maf Clothing Pvt Ltd Unit-3. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2021-12-08.
- Submission: K211487
- Applicant / Sponsor: Maf Clothing Pvt Ltd Unit-3
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2021-12-08
Classification & Regulation
This clearance is catalogued under FDA product code FXX and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.