Clearance Summary
CLINITEX CAST PADDING received FDA 510(k) clearance under submission number K973420, sponsored by Clinitex Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1997-12-09.
- Submission: K973420
- Applicant / Sponsor: Clinitex Medical Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5940
- Decision date: 1997-12-09
Classification & Regulation
This clearance is catalogued under FDA product code LGF and 21 CFR 888.5940, within the Orthopedic review panel as a Class I device.