Clearance Summary
FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE received FDA 510(k) clearance under submission number K031818, sponsored by Facilai Enterprises , 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 2003-12-03.
- Submission: K031818
- Applicant / Sponsor: Facilai Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5580
- Decision date: 2003-12-03
Classification & Regulation
This clearance is catalogued under FDA product code MQX and 21 CFR 880.5580, within the General Hospital review panel as a Class II device.