Clearance Summary
NON-STERILE SUTURE NEEDLES received FDA 510(k) clearance under submission number K881394, sponsored by China National Medicines C/O Havel'S. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1988-04-08.
- Submission: K881394
- Applicant / Sponsor: China National Medicines C/O Havel'S
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1988-04-08
Classification & Regulation
This clearance is catalogued under FDA product code GDL and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.