Clearance Summary
STERILE CAST PADDING received FDA 510(k) clearance under submission number K801554, sponsored by Medi-Spec. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1980-08-04.
- Submission: K801554
- Applicant / Sponsor: Medi-Spec
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1435
- Decision date: 1980-08-04
Classification & Regulation
This clearance is catalogued under FDA product code HIX and 21 CFR 886.1435, within the Ophthalmic review panel as a Class I device.