Clearance Summary
DISPOSA-SPEC received FDA 510(k) clearance under submission number K840593, sponsored by Plasti-Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1984-07-13.
- Submission: K840593
- Applicant / Sponsor: Plasti-Products, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4770
- Decision date: 1984-07-13
Classification & Regulation
This clearance is catalogued under FDA product code ERA and 21 CFR 874.4770, within the Ear, Nose, Throat review panel as a Class I device.