Clearance Summary
STERILE TRACHEOSTOMY CARE KIT received FDA 510(k) clearance under submission number K821501, sponsored by Pro-Pak. 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 1982-06-16.
- Submission: K821501
- Applicant / Sponsor: Pro-Pak
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1982-06-16
Classification & Regulation
This clearance is catalogued under FDA product code KDD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.