Clearance Summary
KANGA PANTS received FDA 510(k) clearance under submission number K781901, sponsored by H.A. & J.E. Wood, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1979-03-06.
- Submission: K781901
- Applicant / Sponsor: H.A. & J.E. Wood, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5920
- Decision date: 1979-03-06
Classification & Regulation
This clearance is catalogued under FDA product code EYQ and 21 CFR 876.5920, within the Gastroenterology, Urology review panel as a Class I device.