Clearance Summary
SOF-WICKLAP PAD received FDA 510(k) clearance under submission number K780718, 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 1978-06-28.
- Submission: K780718
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4450
- Decision date: 1978-06-28
Classification & Regulation
This clearance is catalogued under FDA product code GDY and 21 CFR 878.4450, within the General, Plastic Surgery review panel as a Class I device.