Clearance Summary
LE VEEN WOUND SPLINT received FDA 510(k) clearance under submission number K863570, sponsored by Tek-Aid, Inc.. 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 1986-09-29.
- Submission: K863570
- Applicant / Sponsor: Tek-Aid, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4930
- Decision date: 1986-09-29
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.