Clearance Summary
PERME-AID TRANSPARENT DRESSING, #11XX received FDA 510(k) clearance under submission number K884791, sponsored by Nitto Denko Technical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1989-05-04.
- Submission: K884791
- Applicant / Sponsor: Nitto Denko Technical Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4020
- Decision date: 1989-05-04
Classification & Regulation
This clearance is catalogued under FDA product code NAD and 21 CFR 878.4020, within the General, Plastic Surgery review panel as a Class I device.