Clearance Summary
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 received FDA 510(k) clearance under submission number K160271, sponsored by San-M Package Co., Ltd.. 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 2016-07-15.
- Submission: K160271
- Applicant / Sponsor: San-M Package Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2016-07-15
Classification & Regulation
This clearance is catalogued under FDA product code MSH and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.