Clearance Summary
KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE received FDA 510(k) clearance under submission number K980472, sponsored by American Institute of Koryo Hand Therapy. 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 1998-04-09.
- Submission: K980472
- Applicant / Sponsor: American Institute of Koryo Hand Therapy
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5580
- Decision date: 1998-04-09
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.