Clearance Summary
KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK received FDA 510(k) clearance under submission number K103150, sponsored by Kimberly-Clark. 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 2011-09-23.
- Submission: K103150
- Applicant / Sponsor: Kimberly-Clark
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2011-09-23
Classification & Regulation
This clearance is catalogued under FDA product code OXZ and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.