Clearance Summary
EMERGENCY DEPARTMENT LACERATION KIT- received FDA 510(k) clearance under submission number K802557, sponsored by Johnson & Johnson Professionals, Inc.. 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 1980-11-12.
- Submission: K802557
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1980-11-12
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.