Clearance Summary
PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES received FDA 510(k) clearance under submission number K061517, sponsored by Prime Herbs Corporation. 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 2006-11-22.
- Submission: K061517
- Applicant / Sponsor: Prime Herbs Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5580
- Decision date: 2006-11-22
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.