Clearance Summary
INFLATABLE FULL LEG SPLINT received FDA 510(k) clearance under submission number K874051, sponsored by Vinyl Technology, 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 1987-11-23.
- Submission: K874051
- Applicant / Sponsor: Vinyl Technology, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.3900
- Decision date: 1987-11-23
Classification & Regulation
This clearance is catalogued under FDA product code FZF and 21 CFR 878.3900, within the General, Plastic Surgery review panel as a Class I device.