Clearance Summary
STAINLESS STEEL SOFT SUTURE WIRE received FDA 510(k) clearance under submission number K990355, sponsored by Bregma International Trading Company , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1999-07-08.
- Submission: K990355
- Applicant / Sponsor: Bregma International Trading Company , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1999-07-08
Classification & Regulation
This clearance is catalogued under FDA product code LRN and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.