Clearance Summary
MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 received FDA 510(k) clearance under submission number K882429, sponsored by Tpl-Cordis, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-07-22.
- Submission: K882429
- Applicant / Sponsor: Tpl-Cordis, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3700
- Decision date: 1988-07-22
Classification & Regulation
This clearance is catalogued under FDA product code KRG and 21 CFR 870.3700, within the Cardiovascular review panel as a Class III device.