Clearance Summary
IPI LOW PROFILE IMPORT received FDA 510(k) clearance under submission number K934796, sponsored by Pudenz-Schulte Medical Research Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1994-07-14.
- Submission: K934796
- Applicant / Sponsor: Pudenz-Schulte Medical Research Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 1994-07-14
Classification & Regulation
This clearance is catalogued under FDA product code LJT and 21 CFR 880.5965, within the General Hospital review panel as a Class II device.