Clearance Summary
SOFT TISSUE ANCHORING WASHERS received FDA 510(k) clearance under submission number K030031, sponsored by Accu-Speed, Incorporated. 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 2003-01-28.
- Submission: K030031
- Applicant / Sponsor: Accu-Speed, Incorporated
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4930
- Decision date: 2003-01-28
Classification & Regulation
This clearance is catalogued under FDA product code KGS and 21 CFR 878.4930, within the General, Plastic Surgery review panel as a Class I device.