Clearance Summary
FACE MASK, SURGICAL MASK, NON-STERILE received FDA 510(k) clearance under submission number K970835, sponsored by Tucker & Associates. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1997-09-03.
- Submission: K970835
- Applicant / Sponsor: Tucker & Associates
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1997-09-03
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.