Clearance Summary
Nitta M&T Safety Box received FDA 510(k) clearance under submission number K211464, sponsored by Nitta M&T (Thailand) Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2021-09-14.
- Submission: K211464
- Applicant / Sponsor: Nitta M&T (Thailand) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2021-09-14
Classification & Regulation
This clearance is catalogued under FDA product code MMK and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.