Clearance Summary
THE POUCH GROIN & ABDOMINAL STRESS AID received FDA 510(k) clearance under submission number K892379, sponsored by Kuhn Industries. 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 1989-07-20.
- Submission: K892379
- Applicant / Sponsor: Kuhn Industries
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5160
- Decision date: 1989-07-20
Classification & Regulation
This clearance is catalogued under FDA product code FSD and 21 CFR 880.5160, within the General Hospital review panel as a Class I device.