Clearance Summary
ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA received FDA 510(k) clearance under submission number K974122, sponsored by Scientific Health Care. 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 1998-01-22.
- Submission: K974122
- Applicant / Sponsor: Scientific Health Care
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5580
- Decision date: 1998-01-22
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.