Clearance Summary
HOLY DRAGON ACUPUNCTURE NEEDLES received FDA 510(k) clearance under submission number K002910, sponsored by Anc Import & Export 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 2001-02-07.
- Submission: K002910
- Applicant / Sponsor: Anc Import & Export Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5580
- Decision date: 2001-02-07
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.