Clearance Summary
KIMBERLY-CLARK PROFESSIONAL JACKET received FDA 510(k) clearance under submission number K880385, sponsored by Kimberly-Clark Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1988-02-19.
- Submission: K880385
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6265
- Decision date: 1988-02-19
Classification & Regulation
This clearance is catalogued under FDA product code FME and 21 CFR 880.6265, within the General Hospital review panel as a Class I device.