Clearance Summary
BOUFFANT-STYLE SURGICAL CAP received FDA 510(k) clearance under submission number K863359, sponsored by Kimberly-Clark 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 1986-09-29.
- Submission: K863359
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1986-09-29
Classification & Regulation
This clearance is catalogued under FDA product code FYF and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.